Press Releases

New appointments integrate broad expertise in clinical development, medicine, finance and business management.

CAMBRIDGE, Mass., Aug. 6, 2018 /PRNewswire/ -- AOBiome Therapeutics, Inc. ("AOBiome"), a world-leading clinical-stage microbiome company focusing on research and development of therapeutics for inflammatory conditions, central nervous system disorders and other systemic diseases, today announced the expansion of its Board of Directors with the appointments of (i) Professor Klaus Dugi, Executive Vice President and Chief Medical Officer of Ferring Pharmaceuticals, (ii) Dr. Anna Lisa Jenkins, MBBS, FRCP, Chief Executive Officer of PlaqueTec Ltd. and (iii) Mr. Doug Rosefsky, partner of Prudentia Capital S.A.S., as independent non-executive directors. Mr. Rosefsky will lead the audit committee and Dr. Jenkins will lead the remuneration committee.

"We are very excited to announce the additions of Klaus, Anna Lisa and Doug to the AOBiome Board of Directors," said Mr. Todd Krueger, President and Chief Executive Officer of AOBiome. "These industry veterans bring to AOBiome a broad range of expertise in clinical development, medicine, finance and business management experience. We look forward to benefiting from their strategic insights that will be invaluable to the future direction of the Company."

"It is an honor to bring these seasoned veterans to AOBiome at this important time in the Company's expansion," said Dr. Jun Wang, Chairman of the Board of Directors of AOBiome. "With the company rapidly accelerating its innovative Ammonia Oxidizing Bacteria platform across multiple applications, we are that much closer to achieving our long-term goals within the microbiome space."

Professor Klaus Dugi

Dr. Dugi has over 25 years of experience mainly in the field of medicine. Since 2017, Dr. Dugi has served as Executive Vice President and Chief Medical Officer of Ferring Pharmaceuticals, a multinational pharmaceutical company, and continues to serve in these capacities. His responsibilities at Ferring Pharmaceuticals include medical affairs, pharmacovigilance and quality assurance. In addition, he served at Boehringer Ingelheim, a pharmaceutical company, as Country Managing Director of UK and Ireland from 2015 to 2017, as Chief Medical Officer from 2010 to 2015, as Corporate Vice President of Medical Affairs from 2008 to 2009, and as Vice President of Therapeutic Area Metabolic Diseases from 2006 to 2008. His responsibilities at Boehringer Ingelheim included translational medicine and clinical pharmacology, medical affairs and clinical operations. From 2001 to 2002, Dr. Dugi was the attending physician at the medical clinic of Heidelberg University. He conducted basic and applied biomedical research in the field of atherosclerosis, diabetes and lipid metabolism at the National Institutes of Health in Bethesda, Maryland between 1991 and 1996. He is qualified as a professor of medicine at Heidelberg University, Germany, and he teaches internal medicine and endocrinology at the university.

Anna Lisa Jenkins, MBBS, FCRP

Dr. Jenkins, MBBS, FRCP is currently the Chief Executive Officer of PlaqueTec. Prior to joining PlaqueTec, she was Chief Executive Officer of Dimension Therapeutics, a gene therapy company, until Dimension was acquired by Ultragenyx Pharmaceuticals, a biopharmaceutical company, in 2017. From 2011 to 2014, Dr. Jenkins served at Merck Serono, a German pharmaceutical company, first as its Executive Vice President Global Development and Medical, and then as its Head of Global Research and Development. Prior to this, Dr. Jenkins held several roles at Bristol Myers-Squibb, a global biopharmaceutical company, from 1997 to 2011, including as it Senior Vice President and Head of Global Medical Affairs. Earlier in her career, Dr. Jenkins was a medical officer in the British Royal Navy, achieving the rank of surgeon lieutenant commander.

Doug Rosefsky

Mr. Rosefsky has nearly 25 years of experience mainly in the field of finance, accounting and c-level management. Since July 2017, Mr. Rosefsky has been a partner of Prudentia Capital S.A.S., a private equity fund management company based in France, where he is responsible for investment advisory services. From 1999 to 2015, Mr. Rosefsky was a managing director and European executive committee member of Alvarez & Marsal. From 2010 to 2011, he was an advisor to the board of directors of European Gas Limited, S.A., an oil and gas company listed on the Australian Stock Exchange (stock symbol EPG), which was later renamed as Fitzroy River Corporation Limited (stock symbol FZR). From 2005 to 2007, he served as the Chief Financial Officer and subsequently the Chief Executive Officer at North Atlantic Trading Company and North Atlantic Holding Company, both of which were publicly reported companies and are subsidiaries of Turning Point Brands, Inc., which is listed on the New York Stock Exchange (stock symbol TPB).

About Ammonia Oxidizing Bacteria (AOB)
AOBiome's AOB platform includes patented, proprietary, topical and intranasal formulations which incorporate a single strain of AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB consume ammonia and produce nitrite and nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About AOBiome Therapeutics
AOBiome Therapeutics is a Cambridge, Massachusetts based life sciences company focused on transforming human health by developing microbiome-based therapies for local, intranasal and systemic inflammatory conditions. Founded in 2013 by PatientsLikeMe founder Jamie Heywood and MIT trained chemical engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company's portfolio includes six clinical-stage programs in the following indications; acne vulgaris, hypertension, eczema (atopic dermatitis), migraine, rosacea, and allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at www.aobiome.com.

Contacts:
For Media Inquiries:
Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

Source: AOBiome Therapeutics

AOBiome Advancing Six Programs in Clinical Testing Based on Ammonia Oxidizing Bacteria (AOB) Platform Expertise

CAMBRIDGE, Mass., June 4, 2018 -- AOBiome Therapeutics ("AOBiome"), a world-leading clinical-stage microbiome company focusing on research and development of therapeutics for inflammatory conditions, central nervous system disorders and other systemic diseases, today announced the election of Jun Wang, Ph.D., founder and CEO of iCarbonX, as Chairman of AOBiome's Board of Directors, effective May 31, 2018. Dr. Wang has served on the Board of Directors since 2016.

"On behalf of the AOBiome Board of Directors and its leadership team, we enthusiastically welcome Jun to his new role as the company's Chairman. Throughout his Board tenure, Jun's expertise and clear vision was of great value to us in formulating and overseeing the overall development strategies and business plans of the company, which led to a successful diversification of our development pipeline," said Todd Krueger, President and Chief Executive Officer of AOBiome.

AOBiome is currently advancing six clinical trials of proprietary, topical and intranasal formulations incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The company is also seeking to expand its proprietary development approach to explore and develop additional microbiome programs.

Dr. Jun Wang is the founder and CEO of iCarbonX, a company leading the post-genomic era by creating a platform for digitizing, analyzing, and understanding life. Prior to founding iCarbonX in 2015, Dr. Wang was the CEO and co-founder of BGI (previously known as the Beijing Genomics Institute), one of the world's premier research facilities committed to excellence in genome sciences. During his tenure at BGI, Dr. Wang managed three rounds of fundraising totaling approximately $1 billion, and acquired the U.S.-based public company Complete Genomics. He has authored more than 300 peer-reviewed articles and has been recognized with numerous awards and citations. In addition to his role at iCarbonX, Dr. Wang serves as Ole Rømer Professor at the University of Copenhagen. He received a B.S. in artificial intelligence and a Ph.D. in bioinformatics from Peking University.

"The early successes of our clinical programs have set course for our rapid expansion," stated James Heywood, AOBiome Founder and Board Member. "Pairing Jun's vision with Todd's tactical expertise, AOBiome will continue to seize this moment and significantly accelerate our clinical programs to prove the full value of AOB to human health, and further diversify our pipeline."

"I am honored to serve as the Chairman of AOBiome's Board of Directors at this important time for the company," said Dr. Wang. "Microbiome-based therapies are accelerating at a very fast pace with many new potential applications. AOBiome has propelled its programs forward, leading and innovating unique approaches with its AOB, including industry-first intranasal administration in multiple applications. I look forward to the continued progress of the company."

About Ammonia Oxidizing Bacteria (AOB)
AOBiome's AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produce nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About AOBiome Therapeutics
AOBiome Therapeutics is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by PatientsLikeMe founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company's portfolio includes six clinical-stage programs: A Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, a Phase 2 study to treat patients with atopic dermatitis, a Phase 2 study to treat episodic migraines, a Phase 2 study to study rosacea, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at www.aobiome.com. 

Contacts:
For Media Inquiries:
Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

Source: AOBiome Therapeutics

Patient Dosing Has Begun in First-in-Class Nitric Oxide Modulating, Microbiome-based Therapy 

Cambridge, MA, April 23, 2018 

AOBiome Therapeutics ("AOBiome"), a clinical-stage life sciences company advancing patented microbiome-based therapies, today announced that AOBiome has expanded its clinical-stage pipeline with the initiation of a randomized, double-blind, Phase 2 study to assess safety, tolerability, and efficacy of its first-in-class Ammonia Oxidizing Bacteria (AOB) product candidate as a preventive treatment in episodic migraine. The Company’s AOB will be administered as an intranasal spray, the first application of this delivery approach in a clinical trial for a microbiome-based migraine therapy. AOBiome’s candidate is a single strain of beneficial AOB, Nitrosomonas eutropha, that converts naturally occurring ammonia to nitric oxide, a signaling molecule well-known to regulate inflammation and vasodilation, and to nitrite, altered levels of which are associated with migraines.

"Initiation of our migraine study extends our AOB pipeline to a broad neurology indication for the first time. The trial also further builds on our capabilities in intranasal delivery, which has recently shown promising safety data in treating individuals with seasonal allergic rhinitis," said Todd Krueger, President and Chief Executive Officer of AOBiome.

“Migraine is the third most common illness in the world and is considered one of the top six most disabling illnesses,” said David Kudrow, M.D., director of the California Medical Clinic for Headache, Santa Monica, California. “Options for migraine prevention are currently limited and often demonstrate inadequate efficacy or side effects limiting their usefulness. More than 50% of patients that start preventive medications stop taking them within 6 months either because they are not effective or not well-tolerated. There is a substantial need for new, effective migraine preventive therapies with acceptable safety profiles. I look forward to the progress of AOBiome’s clinical development program for migraine prevention.”

About the Phase 2 Episodic Migraine Trial 
AOBiome’s prospective, randomized, vehicle-controlled, double-blind, Phase 2 study will assess safety, tolerability, and efficacy of the Company’s first-in-class AOB product candidate delivered as an intranasal spray for preventive treatment in 303 subjects with episodic migraine. Patients will be randomized 1:1:1 in three arms (lower dose AOB, higher dose AOB, and vehicle). Safety constitutes the primary clinical endpoint, with secondary endpoints measuring mean change and reductions in migraine days and attacks. Additional information about AOBiome’s Phase 1b/2a study in seasonal allergic rhinitis (SAR) may be found at ClinicalTrials.gov identifier: NCT03488563.

About Ammonia Oxidizing Bacteria (AOB) 
AOBiome’s AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produce nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. 

About Migraine 
Migraine is a chronic, recurrent disorder affecting an estimated 37 million Americans. Around 12% of adults have episodic migraine (headaches on less than 15 days per month). The treatment of migraine often consists of acute/abortive therapies, which, while effective in many cases, may be limited by side effects, the potential for medication overuse/rebound, and some contraindications. Preventive therapies are also used, but current approaches are not disease-specific and are often marked by tolerance issues, such that adherence to therapy is typically low. Nearly half of individuals with episodic or chronic migraine who are in need of preventive therapies do not receive them.

About AOBiome Therapeutics
AOBiome Therapeutics is a Boston-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by PatientsLikeMe founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company’s portfolio includes five clinical-stage programs: a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, a Phase 2 study to treat patients with atopic dermatitis, a Phase 2 study to treat episodic migraines, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.  

Contacts: 
For Media Inquiries: 
Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

Nitric Oxide Modulating Product Candidate Demonstrates Promising Safety and Tolerability in Phase 1b/2a Study

Intranasal Delivery Applicable to Diverse Indications, including Seasonal Allergic Rhinitis (SAR)

AOBiome Therapeutics (“AOBiome”), a clinical-stage life sciences company advancing patented microbiome-targeted therapies, today announced clinical findings from Part 1 of a Phase 1b/2a clinical trial of the Company’s first-in-class Ammonia Oxidizing Bacteria (AOB) product candidate for intranasal delivery. AOBiome’s candidate is a single strain of beneficial AOB, Nitrosomonas eutropha, that converts naturally occurring ammonia to nitric oxide, a signaling molecule well-known to regulate inflammation and vasodilation. In Part 1 of the double-blind, multi-dose, vehicle-controlled Phase 1b/2a trial, AOBiome’s candidate demonstrated promising safety and tolerability when delivered intranasally to healthy volunteers (N=24, randomized 1:1:1 high dose AOB, low dose, and vehicle) over a period of two weeks:

• All adverse events were mild in severity, none of which were considered to be related to the study drug. Additionally, there were no serious adverse events and no discontinuations.
• There were no infectious or inflammatory complications nor local/systemic adverse events related to study drug and no changes in nasal patency, anatomy, or architecture.

Based on these promising results, AOBiome announced that it has initiated Part 2 of its Phase 1b/2a trial to assess preliminary efficacy in subjects with seasonal allergic rhinitis (SAR).

“We are thrilled to announce these latest clinical results, which further underscore the consistently compelling safety findings for our AOB candidate across modalities, including topical and now intranasal delivery,” said Todd Krueger, President and Chief Executive Officer of AOBiome. “We believe our intranasal approach has a number of potential applications beyond rhinitis, including migraines.”

Mr. Krueger continued, “Achievement of this milestone also signals AOBiome’s leadership in translating its novel microbiome-related science into rigorous clinical programs with relevance to human health and disease. We believe we are at the forefront of this rapidly evolving field, and we will continue to drive earlier-stage discoveries across multiple platforms, applying our expertise in systems chemistry and next-generation sequencing technologies to understanding the role and therapeutic benefits of the human microbiome.”

About the Phase 1b/2a Trial
AOBiome’s Phase 1b/2a clinical trial of their AOB product candidate is a randomized, multi-dose, double-blind, vehicle-controlled study designed to evaluate safety and tolerability in up to 24 healthy volunteers and preliminary efficacy as a prophylaxis therapy in up to 42 individuals with a history of SAR due to ragweed pollen. Additional information about AOBiome’s Phase 1b/2a study in SAR may be found at ClinicalTrials.gov, using Identifier NCT: NCT03290248.

About Ammonia Oxidizing Bacteria (AOB)
AOBiome’s AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produce nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About Seasonal Allergic Rhinitis
Seasonal allergic rhinitis (SAR) is an inflammatory disease in which exposure to outdoor allergens, such as plant pollen or mold spores, results in inflammation of the nasal passages. Individuals with allergic rhinitis may experience symptoms including sneezing, runny nose, nasal itch, and nasal congestion, which can have a significant impact on patients depending on the degree of severity. According to the Centers for Disease Control and Prevention, SAR affects nearly 8% of the U.S. population (see reference for 2015 statistics). Unmet needs in SAR are substantial, particularly in regard to achieving a balance between potential side effects and adequate symptom control.

About AOBiome Therapeutics
AOBiome Therapeutics is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by PatientsLikeMe founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company’s portfolio includes three clinical-stage programs, a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.

Contacts
For Media Inquiries:
Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

AOBiome Therapeutics (“AOBiome”) today announced that Todd Krueger has been named Chief Executive Officer, effective immediately. Mr. Krueger retains his current role as President, a position he has held since March 2016. AOBiome is a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions.

“We are very pleased to have Todd take on the role of CEO at this pivotal time for AOBiome,” said AOBiome’s Chairman and Co-Founder Jamie Heywood. “The company is advancing multiple mid-clinical stage programs based on its first-in-class Ammonia Oxidizing Bacteria (AOB) platform, which we expect will have key data readouts over the course of the next year and into 2019. Todd’s exemplary track record and his unique expertise across healthcare strategy, business development, and operations will be essential in guiding the company through its next stage of development.”

Mr. Krueger joined AOBiome in May 2015 as Chief Business Officer, prior to which he served as Head of Commercial Strategy and Operations for the Genomics Platform at the Broad Institute. Previously, Mr. Krueger held senior positions at Life Technologies, including Head of Business Development for Genetic Systems and Head of Business Development for Molecular Medicine, focused on the company’s companion diagnostics business. He has also been involved in the founding of several biotechnology companies, including Gynesonics, Nodality, and Anestis Therapeutics. In 1999, he co-founded Fluidigm Corporation, a publicly traded life sciences technologies and tools company, where he served as CFO and Vice President of Business Development. Mr. Krueger is a member of the Board of Directors for multiple companies, including General Automation Lab Technologies (GALT), a microbiome tools company. He started his career as a consultant for Bain and Company in Boston. Mr. Krueger graduated Highest Distinction from Northwestern University with a degree in Economics and earned his MBA from the Kellogg School of Management.

“It has been a privilege to work closely with the accomplished team at AOBiome as we have advanced and expanded our development pipeline targeting diverse inflammatory conditions,” said Todd Krueger, President of AOBiome. “In 2018 and beyond we will continue to focus on developing innovative clinical programs and applying our world-class scientific platform to address areas of compelling unmet patient needs.”

About AOBiome

AOBiome Therapeutics is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by PatientsLikeMe founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company’s portfolio includes three clinical-stage programs, a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.

Contacts:
For Media Inquiries Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

First-in-Class Therapy Demonstrates Statistically Significant 2-Point Reduction (p=0.03) in Investigator’s Global Assessment (IGA) 

AOBiome Therapeutics (“AOBiome”), a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, today announced positive efficacy and safety findings from the Phase 2b clinical trial of the Company’s Ammonia Oxidizing Bacteria (AOB) product candidate for the treatment of mild-to-moderate acne vulgaris. AOBiome’s candidate is a first-in-class, topical formulation of a single strain of beneficial AOB, Nitrosomonas eutropha. The Phase 2b study achieved the primary endpoint at week 12 of a statistically significant 2-point reduction in an Investigator’s Global Assessment (IGA) of acne severity compared to vehicle control (p=0.03). The study also showed a trend in the reduction of the number of inflammatory lesions compared to control, a second primary endpoint; this difference reached statistical significance in the per protocol treatment group (p=0.028, log transformation analysis). AOBiome’s candidate was well-tolerated, demonstrating no treatment-emergent adverse events.

“We are proud of the continued success and progress of our acne program. This, coupled with the recently announced initiation of our Phase 1b/2a clinical trial for allergic rhinitis, highlights the versatility and broad utility of our anti-inflammatory platform.” said Todd Krueger, President of AOBiome. “Application of our AOB to more than 270 individuals across disease areas with virtually no side effects underscores the potential of our platform to address inflammation contributing to a broad range of diseases, supporting our continued leadership in the development of innovative therapeutics.”

AOBiome’s randomized, double-blind, placebo-controlled Phase 2b study evaluated AOB in 358 adults with mild-to-moderate acne vulgaris. Primary outcome measures of the Phase 2b study were designed to assess safety and efficacy as demonstrated by an Investigator Global Assessment and reduction in inflammatory and non-inflammatory lesion count during the 12-week treatment period. The Phase 2b study was jointly conducted with Science 37, a clinical research company, that has pioneered a “site-less” clinical trial model with its proprietary mobile technology, the Network Oriented Research Assistant (NORA®) used in the trial to capture real-time data from patients at their homes. The Principal Investigator of the study was Noah Craft MD, PhD, a dermatologist, microbiologist, and CEO of Science 37, Inc. A previous Phase 1b/2a dose-ranging safety study resulted in no serious adverse events and no difference in adverse events between treatment and vehicle groups. Additional information about AOBiome’s Phase 2b study in acne may be found at ClinicalTrials.gov, using Identifier NCT: NCT02832063.

“We are very excited by these positive findings, which to our knowledge are the first to demonstrate that a single strain of beneficial AOB can have a clinically meaningful impact on acne, a known challenge with current available therapies,” stated Chief Medical Officer, Larry Weiss, MD. “In addition, safety and side effects are important challenges with marketed products and our ability to reduce disease severity with no treatment-related safety events offers a potentially differentiated profile to available interventions.”

Given the positive results of the Phase 2b study in acne, AOBiome plans to expand its dermatology platform to include atopic dermatitis, pruritus, and rosacea.

About Ammonia Oxidizing Bacteria (AOB)
AOBiome’s AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB normally found on the body. Once deployed, AOB convert ammonia to nitrite, which is known to have antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About Acne
Acne affects approximately 40 to 50 million people in the U.S., where it is the most common skin condition and the top reported cause for dermatologist visitations, accounting for about one-fourth of U.S. dermatologists’ patient volume. U.S. sales of the Top 10 branded acne therapeutics have a $3 billion run rate. However, despite the significant spend on prescription and over the counter remedies, acne remains an area of significant unmet medical need as treatments are either marginally effective (topical antibiotics, topical retinoids, astringents) and/or associated with serious risks (oral retinoids).

About AOBiome Therapeutics
AOBiome Therapeutics is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by Patients Like Me founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical stage therapeutic candidates. The company’s portfolio includes three clinical stage programs, a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.

Contacts:

For Media Inquiries Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

First-in-Class Therapy Enables Intranasal Delivery of Nitric Oxide 

AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, today announced the initiation of patient enrollment in AOBiome’s Phase 1b/2a clinical trial of the Company’s Ammonia Oxidizing Bacteria (AOB) product candidate, for the treatment of seasonal allergic rhinitis (SAR). The initiation of enrollment represents a first-in-class, intranasal formulation incorporating a single strain of beneficial ammonia-oxidizing bacteria (AOB), Nitrosomonas eutropha. Once administered, the AOB convert naturally occurring ammonia to nitric oxide, a signaling molecule well-known to regulate inflammation and vasodilation.

“AOBiome continues its leadership in innovation with the initiation of what we believe is the first FDA-supported clinical study to test intranasal application of a microbiome-targeted therapy,” said Todd Krueger, President of AOBiome. “The SAR trial is designed to provide early evidence for the potential efficacy of our approach as a prophylactic treatment for those who suffer from seasonal allergies. In addition, we look forward to establishing safety and tolerability with another route of delivery, which will allow us to pursue a broader range of diseases that are amenable to intranasal delivery.” To date, AOBiome’s AOB formulations have been tested in more than 270 individuals, with no serious adverse events and no difference in adverse events between treatment and vehicle groups.

AOBiome’s Phase 1b/2a clinical trial of their AOB product candidate is a randomized, double-blind, vehicle-controlled study designed to evaluate safety and tolerability in up to 24 healthy volunteers and preliminary efficacy as a prophylaxis therapy in up to 42 individuals with a history of SAR due to ragweed pollen. Additional information about AOBiome’s Phase 1b/2a study in SAR may be found at ClinicalTrials.gov, using Identifier NCT: NCT03290248.

“Current treatments for SAR are frequently associated with local and/or systemic adverse effects that can cause many patients to pursue alternative strategies for control of their symptoms,” stated Chief Medical Officer, Larry Weiss, MD. “Our platform seeks to address SAR through a novel approach, adjusting human commensal bacteria in the nasal microbiome to rebalance inflammatory processes underlying disease. We look forward to sharing the progress of our clinical program utilizing intranasal delivery.”

About Ammonia Oxidizing Bacteria (AOB) AOBiome’s AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB normally found on the body. Once deployed, AOB convert ammonia to nitrite, which is known to have antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About Seasonal Allergic Rhinitis Seasonal allergic rhinitis (SAR) is an inflammatory disease in which exposure to outdoor allergens, such as plant pollen or mold spores, results in inflammation of the nasal passages. Individuals with allergic rhinitis may experience symptoms including sneezing, runny nose, nasal itch, and nasal congestion, which can have a significant impact on patients depending on the degree of severity. According to the Centers for Disease Control and Prevention, SAR affects nearly 8% of the U.S. population (see reference for 2015 statistics). Unmet needs in SAR are substantial, particularly in regard to achieving a balance between potential side effects and adequate symptom control.

About AOBiome AOBiome is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local and systemic inflammatory conditions. Founded in 2013 by Patients Like Me founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of novel therapeutic candidates for systemic, nasal, and local conditions. AOBiome’s lead programs include two mid-stage clinical trials: a Phase 2b study to treat patients with acne vulgaris and a Phase 2 trial to reduce elevated blood pressure. Additionally, the Company is advancing a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.

Contacts:

For Media Inquiries Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com 

First-in-Class Therapy to Locally Deliver Nitric Oxide.

Ongoing Phase 2b Study with Lead Candidate in Individuals with Mild-to-Moderate Acne Vulgaris 

AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, today announced that the United States Patent and Trademark Office (USPTO) has issued a patent covering the Company’s Ammonia Oxidizing Bacteria (AOB) for the treatment of acne. The lead candidate is currently in development for multiple indications, including an ongoing Phase 2b study for acne vulgaris, and multiple earlier-stage clinical studies for allergic rhinitis and other inflammatory conditions. U.S. Patent No. 9,738,870 is directed to methods of use for AOB for the treatment of inflammatory or non-inflammatory lesions in individuals with acne vulgaris. “AOBiome is continuing to build a broad portfolio of patents and patent applications encompassing composition and methods of preparation and use across diverse therapeutic applications with compelling unmet needs,” said Todd Krueger, President of AOBiome. “We are pleased with the progress of our lead program with AOB in our ongoing Phase 2b clinical trial, which recently completed the last patient visits for individuals with mild-to-moderate acne vulgaris. We expect this study will provide important information regarding the potential of our promising therapeutic agent to treat acne while avoiding both local and systemic adverse effects that are often associated with current standard of care.” About Ammonia Oxidizing Bacteria (AOB)

AOBiome’s AOB platform is a patented, proprietary, topical formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha D23. The platform is designed to repopulate the skin microbiome with AOB normally found on the body, but frequently stripped away by most soaps. Once deployed on the skin, AOB convert ammonia to nitrite, which is known to have antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. The Company’s multicenter, randomized, double-blind, placebo-controlled Phase 2b study is evaluating AOB in 358 adults with mild-to-moderate acne vulgaris. Primary outcome measures of the Phase 2b study are designed to assess safety and efficacy as demonstrated by Investigator Global Assessment and reduction in inflammatory and non-inflammatory lesion count during the 12-week treatment period. The Phase 2b study is being jointly conducted with Science 37, a clinical research organization. A previous Phase 1b/2a dose-ranging safety study resulted in no serious adverse events and no difference in adverse events between treatment and vehicle groups. About Acne

Acne affects approximately 40 to 50 million people in the U.S., where it is the most common skin condition and the top reported cause for dermatologist visitations, accounting for about one-fourth of U.S. dermatologists’ patient volume. U.S. sales of the Top 10 branded acne therapeutics have a $3 billion run rate. However, despite the significant spend on prescription and over the counter remedies, acne remains an area of significant unmet medical need as treatments are either marginally effective (topical antibiotics, topical retinoids, astringents) and/or associated with serious risks (oral retinoids). About AOBiome

AOBiome is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local and systemic inflammatory conditions. Founded in 2013 by Patients Like Me founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of novel therapeutic candidates for systemic and local conditions. AOBiome’s lead programs include two mid-stage clinical trials: a Phase 2b study to treat patients with acne vulgaris and a Phase 2 trial to reduce elevated blood pressure. Additionally, the Company is progressing clinical trials in allergic rhinitis and earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.

Contacts:

For Media Inquiries Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com 

First-in-Class Therapy Designed to Deliver Nitric Oxide for Application in Diverse Inflammatory Conditions

AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, announced today completion of patient enrollment in the Company’s Phase 2 clinical trial of its lead product candidate, designated B244, to treat individuals with elevated blood pressure. The multicenter, randomized, double-blind, vehicle-controlled Phase 2 study is evaluating B244, a first-in-class, topical formulation of beneficial ammonia-oxidizing bacteria (AOB), in up to 116 individuals with either systolic prehypertension or systolic Stage 1 hypertension. Primary outcome measures of the Phase 2 study will address safety and provide an initial efficacy readout comparing mean reductions in systolic blood pressure in active and vehicle control groups in the 4-week treatment period.

“We are pleased with the rapid advancement of our Phase 2 program, which featured an effective patient recruitment campaign conveying the advantages of topical therapeutic application,” said Todd Krueger, President of AOBiome. “The principal goal of the Phase 2 trial will be to confirm previous clinical findings, including positive safety results and data demonstrating the potential to lower blood pressure in human subjects. Based on our progress, we anticipate completing the trial in the second half of this year.”

A previously conducted Phase 1b/2a acne study of B244 reported no serious adverse events and no difference in adverse events between treatment and vehicle groups among patients with acne vulgaris, an indication currently being tested in an ongoing Phase 2b study. Results from the Phase 1b/2a acne trial also showed dose-dependent reductions in blood pressure in normotensive subjects, achieving statistically significant decreases compared to placebo in patients receiving the highest treatment dose.

AOBiome’s B244 is a patented, proprietary, topical formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha D23. B244 is designed to repopulate the skin microbiome with AOBs normally found on the body, but frequently stripped away by most soaps. Once deployed on the skin, B244 converts ammonia to nitrite, which is known to have antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

“The ability to reliably and effectively deliver nitric oxide may benefit individuals with elevated blood pressure, including prehypertensive patients and those with Stage 1 hypertension, many of whom wish to avoid the adverse effects associated with currently approved blood pressure medications,” stated Chief Medical Officer, Larry Weiss, MD. “Pending further confirmation in clinical studies, the promising safety data and blood pressure lowering activity of B244 have the potential to profoundly affect the quality of life of patients, and I look forward to the continued progress of the program.”

About AOBiome
AOBiome is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local and systemic inflammatory conditions. Founded in 2013 by Patients Like Me founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of novel therapeutic candidates for systemic and local conditions. AOBiome’s lead programs include two mid-stage clinical trials: a Phase 2b study to treat patients with acne vulgaris and a Phase 2 trial to reduce elevated blood pressure. Additionally, the Company is progressing clinical trials in allergic rhinitis and eczema and earlier-stage preclinical programs targeting diverse indications. Learn more at AOBiome.com.

Contacts:

For Media Inquiries:

Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com 

Improving the Appearance of Keratosis Pilaris with Ammonia Oxidizing Bacteria

Presented at the Late-breaking Forums during the 2017 Annual Meeting in Orlando, FL, March 3-7, 2017 by:

Dr. Nicole Lee, MD, MPH

Saturday, March 4 from 10:50 AM – 11:00 AM

AUTHORS: Nicole Y Lee¹, MD, MPH, Shilpi Khetarpal¹, MD, Kathleen G Petrell¹, Mariya Gaber², Spiros Jamas², ScD, Ioannis Gryllos², PhD, D. Davidson Easson Jr², ScD, Jeffrey S Dover¹, MD, FRCPC

¹ SkinCare Physicians, Chestnut Hill, MA
2AOBiome, LLC, Cambridge, MA

ABSTRACT

Keratosis pilaris is a common skin condition presenting as follicular hyperkeratotic papules on proximal extremities. The appearance is disturbing to patients and current therapies are limited. Nitric oxide (NO) is essential in systemic and cutaneous physiologic function, specifically its anti-microbial and anti-inflammatory properties, which evolutionarily may have been maintained by ammonia-oxidizing bacteria (AOB). We hypothesized that topical skin application of AOB (Nitrosomonas eutropha), a biological delivery system of nitrite and NO, could benefit KP patients. We evaluated tolerability and efficacy in a double-bind, placebo-controlled, bilateral study in subjects with KP on both arms and legs.

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