Press Releases

• The newly issued patent covers Composition of Matter for AOBiome’s proprietary strain of Ammonia Oxidizing Bacteria (AOB), along with additional claims pertaining to a variety of related methods including use thereof in changing a composition of a skin microbiome of a subject, inhibiting microbial growth on a subject’s skin, and treating or preventing a skin disorder.
• AOBiome’s clinical candidate B244 has demonstrated clinical efficacy on multiple therapeutic indications including: Mild-to-Moderate Atopic Dermatitis (Eczema) and associated Moderate-to-Severe Pruritus (Itch), and mild-to-moderate Acne Vulgaris (Acne)
• AOBiome is currently preparing for its Global Phase 3 trial for the treatment of Atopic Dermatitis and associated Pruritus, as well as a Phase 2 study in moderate to severe Acne Vulgaris

CAMBRIDGE, Mass., October 2, 2024 /EIN Presswire/ — AOBiome Therapeutics, Inc. (“AOBiome”), a leading clinical-stage biotech company focusing on inflammatory conditions, today announced that the United States Patent Office (USPTO) has issued a composition of matter patent, U.S. Patent No. 12,091,652, with claims focused on its proprietary strain of beneficial AOB (Ammonia Oxidizing Bacteria), in the class of Nitrosomonas eutropha. The base patent term extends until November 3, 2035, excluding patent term extensions or coverage in additional related patent filings.

AOBiome’s B244 proprietary strain is delivered via a simple to use topical spray.  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.  It has also been demonstrated that this strain of AOB can reduce the inflammatory and pruritic cytokines, including IL-4, IL-5, IL-13, and IL-31 which are hallmarks of atopic response.

The Company completed a Phase 2b study of 547 patients with mild-to-moderate atopic dermatitis and associated moderate-to-severe pruritus. B244 showed continued durability of treatment effect and separation from placebo post-treatment of 41.1% reduction in itch from baseline at 8 weeks, 4 weeks after the last dose.  This and other clinical trials have also demonstrated the unique safety profile of B244, with no treatment related SAE’s reported on any of the over 1,000+ patients that have participated in its trials.

This issuance follows the granting of the patent in numerous non-US territories including: Australia, Canada, China, France, Germany, Hong Kong, India, Japan, Korea and United Kingdom. The composition of matter patent gives an extra measure of protection to the already issued use patents that cover the clinical areas the company is pursuing, including Acne, Atopic Dermatitis, Rosacea, Psoriasis and other inflammatory skin diseases.   AOBiome has also been granted other patents, in the US and internationally, covering manufacturing, quality assurance and product delivery.

“Getting a composition of matter patent speaks to the unique aspects of this proprietary strain of AOB which has shown superior growth, stability and metabolic activity when compared to other strains.  This coupled with our existing issued use patents for the entire class of AOB gives us a unique position in the marketplace” says President & CEO, Todd Krueger.

AOBiome is currently preparing for its Global Phase 3 trial for the treatment of Atopic Dermatitis (Eczema) and associated Pruritus (Itch).  The Phase 3 trial will include 2 arms of 934 each with a 900 person OLE.  The trial will study both Adults and Children down to the age of 12 years.  A follow-on study is planned for children down to the of 3 months.  The trial will be run in the US, Europe and Japan in conjunction with AOBiome’s licensing partner Maruho.

About B244

AOBiome’s B244 platform is a patented, proprietary, topical formulation. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be safe and well-tolerated in clinical studies to date.

Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31. See full article at: https://www.nature.com/articles/s41598-021-93299-1.

About AOBiome Therapeutics, Inc.

AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at www.aobiome.com.

Contacts:

For Media Inquiries:
Jim Hoffman
+1.617.639.9980
Press@AOBiome.com

Microbiome Therapeutics: Out of Range or Just Under the Radar?

Osaka (Japan), January 10, 2024 – Maruho Co., Ltd. (“Maruho”; Head Office: Osaka; President and CEO, Atsushi Sugita) announces that it has entered into an exclusive license agreement (the “Agreement”) with AOBiome, LLC (“AOBiome”, Head Office: Cambridge, Massachusetts (USA); President and CEO, Todd Krueger) for B244 (development code) for the treatment of atopic dermatitis.

Under the license agreement, AOBiome grants Maruho an exclusive license to develop, manufacture, and commercialize B244 in Japan, and Maruho will pay AOBiome an upfront payment. Maruho may also make additional milestone payments depending on achievement of development and commercialization milestones. Maruho also has the rights to B244 for additional diseases other than atopic dermatitis.

Maruho plans to advance the development of B244 in Japan by participating in the global Phase 3 clinical studies that AOBiome is planning in Japan, the U.S. and Europe for the treatment of adult patients with atopic dermatitis.

B244 is a topical biologic formulation being developed by AOBiome, leveraging ammonia-oxidizing bacterium. B244 reduces the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31¹⁾. In a late stage Phase 2 clinical study conducted in the U.S. by AOBiome in adult patients with atopic dermatitis, B244 was found to be safe and effective for the treatment of appearance and itching related to atopic dermatis²⁾.

Maruho is committed to contributing to the smiles of patients by providing a new treatment option for atopic dermatitis.

NoteThe information contained in this news release in regard to pharmaceutical and developmental products is not intended for the purpose of promotion, advertising or medical advice.

About AOBiomeAOBiome, LLC. is a Cambridge, MA-based life sciences company. AOBiome is engaged in the development of topical therapeutics for inflammatory conditions using its live biotherapeutic B244. For more information, please visit https://www.aobiome.com/

About Ammonia Oxidizing BacteriaAmmonia Oxidizing Bacteria is a general term for bacteria that oxidize ammonia to nitric oxide and nitrite. The genus Nitrosomonas is a representative example.

About MaruhoMaruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,566 employees (as of the end of September 2023), and net sales were approximately 85.71 billion yen in its fiscal year ended September 30, 2023. With the mission “More smiles, brighter life for you.”, Maruho aims to help realize a society where everyone can live with a smile.
For more information, please visit www.maruho.co.jp/english/

References1）https://www.aobiome.com/aob-inflammatory-conditions-and-systemic-effects/
2）https://www.aobiome.com/press/press-releases/?y=2023

Contact Information:

Maruho Co., Ltd.

Public Relations Group, Corporate Planning Dept.

Tel：+81-(0)6-6371-8831 Fax：+81-(0)6-6371-8679

e-mail：kouhou@mii.maruho.co.jp

• The license is exclusive for the territory of Japan and contains rights for future indications
• Maruho is responsible for conducting and bearing costs for development in Japan, which will be conducted jointly with AOB Pharma as part of a Global Phase 3 Study for Atopic Dermatitis encompassing Japan, the US, and EU
• The deal includes upfront payments, milestone payments and ongoing royalties.

CAMBRIDGE, Mass., January 5, 2024 /PRNewswire/ — AOBiome Therapeutics Inc. (“AOB”), a leading clinical-stage microbiome company focusing on inflammatory conditions, announced today that is has entered into an exclusive license and development agreement with Maruho Co., Ltd., to develop and commercialize AOB’s topical biologic B244 (currently preparing for global Phase 3 clinical trials), a therapeutic treatment for dermatological indications including Atopic Dermatitis, for both appearance and pruritus (itch).   The license is for all indications treated by the B244 platform.

Under the license agreement, Maruho will commercialize the product exclusively in Japan. Based on the license agreement, AOB will supply the product to Maruho, and Maruho will make an upfront payment and may also make additional milestone payments depending on achievement of development and commercialization milestones.  Maruho also has the rights to AOB’s B244 for all additional indications including later stage programs related to inflammation.

“B244 offers an opportunity to extend our portfolio for the treatment of Atopic Dermatitis as well as other inflammatory indications.  It’s unique safety profile and efficacy will allow us to continue our leadership in treating Atopic Dermatitis while improving patients’ lives.  We look forward to continuing to develop the treatment in collaboration with AOB Pharma.” says Atsushi Sugita, President and CEO of Maruho.

“We are excited to be partnering with Maruho as they are the leading dermatology player in Japan.  We view this as validation of B244’s potential to address unmet market needs, not just in Japan but globally.  We could not have found a better collaborator as we develop our programs for Japanese patients.  This model will serve as an example as we fill out our worldwide strategy.” says AOBiome’s President & CEO, Todd Krueger.

AOB is in the process of planning global Phase 3 studies for B244 in Atopic Dermatitis, for which it aims to start recruiting patients in the second half 2024.  The Japanese portion of the Phase 3 trials will be run in Japan by Maruho.

About B244

AOB’s B244 platform is a patented, proprietary, topical formulation. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be well-tolerated in clinical studies to date.

Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31.  See full article at: https://www.nature.com/articles/s41598-021-93299-1.

About AOB Therapeutics, Inc.

AOBiome Therapeutics Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOB is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at AOBPharma.com.

About Maruho

Maruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,547 employees (as of the end of September 2022), and net sales were approximately 85.67 billion yen in its fiscal year ended September 30, 2022. With the mission “More smiles, brighter life for you.”, Maruho aims to help realize a society where everyone can live with a smile.

For more information, please visit https://www.maruho.co.jp/english/

Contacts:

For Media Inquiries:

Jim Hoffman

845-417-3487

Press@AOBiome.com

SOURCE AOBiome Therapeutics

• The peer-reviewed publication describes the significant effects of B244 in 4 weeks across key endpoints in adult patients with atopic dermatitis and associated pruritus (itch) in the largest study of B244 to date.
• The study demonstrated significant efficacy of B244 across all clinical endpoints, including the improvement of itch, eczema severity, and quality of life metrics.
• Study results reiterate B244’s strong safety profile at all dose levels, confirming prior clinical trial safety results.
• B224 is an investigational therapy currently under regulatory review in the U.S. These study results support the advancement of B244 to Phase 3.

CAMBRIDGE, Mass., May 16, 2023 /PRNewswire/ — AOBiome Therapeutics, Inc. (“AOBiome”), a leading clinical-stage biotech company focusing on inflammatory conditions, today announces that The Lancet’s eClinicalMedicine, a peer-reviewed medical journal, has published a report describing the Company’s Phase 2b clinical data for its B244 treatment for mild-to-moderate atopic dermatitis and moderate-to-severe pruritus. The paper, titled “Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: a randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial,” provides a detailed analysis of the Phase 2b trial, showing that B244 demonstrated significant improvements in eczema severity and itch reduction. The article can be freely accessed  via the following link: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00179-7/fulltext

In the trial, 547 patients were assigned to a high-dose, low-dose, or placebo group. The trial was run across more than 50 clinical sites in the US, in collaboration with Biorasi, LLC, a leading Clinical Research Organization. After 4 weeks of use, the following key results were obtained:

• Itch was reduced by 34% (-2.8 B244 vs -2.1 Placebo) compared to placebo, as measured by the Worst Itch Numeric Rating Score (WI-NRS) and achieved a clinically meaningful itch response (30.8% B244 vs 21.8% Placebo in ≥4-point improvement in WI-NRS from baseline).
• Eczema severity improvements were also seen, with 29.3% and 27.7% of patients in the high and low dose groups of B244 achieving EASI-75 success vs. 15.8% in the placebo group and with 26.2% and 21.7% of patients in the high and low dose groups of B244 achieving IGA success (≥2-point improvement in IGA to clear or almost clear) vs. 12.3% in the placebo group.
• B244 was well-tolerated, with no serious adverse events. Treatment-emergent adverse events (TEAE) and treatment-related TEAEs were infrequent, mild, and transient.

Dr. Jonathan Silverberg, Director of Clinical Research at the George Washington University School of Medicine and Health Sciences, says “B244 is a promising new non-steroidal therapy for AD, with a very novel mechanism of action. The study was well designed and the results are very promising. B244 may address a number of unmet needs for atopic dermatitis patients.”

According to Todd Krueger, President and CEO of AOBiome Therapeutics, Inc., “This publication represents the recognition of B244’s efficacy and differentiation in addressing this population.  The fact it has so few side effects reinforces the commercial opportunity to become first line therapy before patients escalate to more expensive, risky, or invasive therapies.”

About B244

AOBiome’s B244 platform is a patented, proprietary, topical formulation of ammonia oxidizing bacteria. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be safe and well-tolerated in clinical studies to date.

Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, and IL-13. See full article at: https://www.nature.com/articles/s41598-021-93299-1.

About AOBiome Therapeutics, Inc.

AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at www.aobiome.com.

About Biorasi

Biorasi is a customer-focused, full-service, contract research organization (CRO) that delivers fast and flexible solutions across global clinical trials to maximize speed-to-market for its sponsors. As the leader in clinical trials for dermatology, neurology, oncology, and the rare disease market, Biorasi sets new benchmarks for speed, agility, and quality in patient enrollment, decentralized trials, and data sciences. Contact Biorasi at info@biorasi.com / (786) 388-0700 or visit us online at www.biorasi.com.

Contacts:

For Media Inquiries:
Jim Hoffman
845-417-3487
Press@AOBiome.com

• The newly issued patent covers Composition of Matter for AOBiome’s proprietary strain of Ammonia Oxidizing Bacteria (AOB), along with additional claims pertaining to a variety of related methods including use thereof in changing a composition of a skin microbiome of a subject, inhibiting microbial growth on a subject’s skin, and treating or preventing a skin disorder.
• AOBiome’s clinical candidate B244 has demonstrated clinical efficacy on multiple therapeutic indications including: Mild-to-Moderate Atopic Dermatitis and associated Moderate-to-Severe Pruritus, and mild-to-moderate Acne Vulgaris
• AOBiome is currently preparing for its Phase 3 trials for the treatment of Atopic Dermatitis (Eczema) and associated Pruritus (Itch).

CAMBRIDGE, Mass., April 6, 2023 /PRNewswire/ — AOBiome Therapeutics, Inc. (“AOBiome”), a leading clinical-stage biotech company focusing on inflammatory conditions, today announced that the European Patent Office (EPO) has issued a composition of matter patent, EP Patent No. 3132021, with claims focused on its proprietary strain of beneficial AOB, in the class of Nitrosomonas eutropha. The base patent term extends until April 15, 2035, excluding patent term extensions or coverage in additional related patent filings.

The proprietary strain is delivered via a simple to use topical spray.  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.  It has also been demonstrated that this strain of AOB can reduce the inflammatory and pruritic cytokines, including IL-4, IL-5, IL-13, and IL-31 which are hallmarks of atopic response.

The Company completed a Phase 2b study of 547 patients with mild-to-moderate atopic dermatitis and associated moderate-to-severe pruritus. B244 showed continued durability of treatment effect and separation from placebo post-treatment of 41.1% reduction in itch from baseline at 8 weeks, 4 weeks after the last dose.  This and other clinical trials have also demonstrated the unique safety profile of B244, with no treatment related SAE’s reported on any of the over 1,000+ patients that have participated in its trials.

The EP approval also provides patent coverage in Hong Kong.  This patent follows on other related issued composition of matter patents in Japan, Canada, India and Australia.  AOBiome has also been granted patents for the use of AOB on the treatment of Acne, Eczema, Rosacea and Psoriasis along with other patents covering manufacturing, quality assurance and product delivery.

“Getting a composition of matter patent speaks to the unique aspects of this proprietary strain of AOB which has shown superior growth, stability and metabolic activity when compared to other strains.  This coupled with our existing issued use patents for the entire class of AOB gives us a unique position in the marketplace” says President & CEO, Todd Krueger.

About B244

AOBiome’s B244 platform is a patented, proprietary, topical formulation. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be safe and well-tolerated in clinical studies to date.

Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31. See full article at: https://www.nature.com/articles/s41598-021-93299-1.

About AOBiome Therapeutics, Inc.

AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at www.aobiome.com.

Contacts:

For Media Inquiries:
Jim Hoffman
845-417-3487
Press@AOBiome.com

AOBiome Therapeutics – Pioneering a Revolutionary Remedy for Skin Inflammatory Disorders

https://businesstalkmagazine.com/interviews/todd-krueger-pioneering-a-revolutionary-remedy-for-skin-inflammatory-disorders/

AOBiome Therapeutics – Transforming Human Health via Novel Microbiome-Based Therapies for Inflammatory Conditions

https://thesiliconreview.com/magazine/profile/aobiome-therapeutics-transforming-human-health/

 

https://www.ceocfointerviews.com/pdfs/AOBiomeTherapeutics22-CEOCFOMagazine-Interview.pdf