Press Releases

Funding to Advance Clinical Research on Systemic and Topical Inflammatory Disorders Using Novel Bacterial Platform

Leading microbiome company AOBiome announced it has partnered with iCarbonX, China’s largest health data collection and analysis platform. iCarbonX was founded in 2015 by renowned genomicist Jun Wang, whose iCarbonX ecosystem has made a $30 million investment in AOBiome. The investment reinforces the ascent of AOBiome as a leader in microbiome drug development, and is underscored by the recent launch of its Phase 2 clinical trial employing the company’s novel bacterial platform for treatment of hypertension. This is the second major clinical trial from AOBiome’s portfolio of therapeutic targets for ammonia-oxidizing bacteria (AOB), following the initiation of its acne vulgaris Phase 2B trial last fall. Once deployed, AOBiome’s proprietary AOBs consume ammonia and produce nitrite and nitric oxide, key signaling molecules known to regulate inflammation and vasodilation.

“Modern hygiene practices eliminate AOB’s that humans have co-evolved with. The loss of AOB’s may cause an imbalance in the nitrogen cycle, leading to excess ammonia and deficiencies in nitric oxide and nitrite, contributing to systemic inflammation,” said Todd Krueger, President of AOBiome. “iCarbonX is an ideal strategic partner to help us understand where and how repopulating AOBs has the potential to resolve a broad range of modern diseases and improve systemic health.” AOBiome is advancing a new Germ Theory of Health by reintroducing keystone commensal bacteria to our body’s natural microbiome. In the last 10 years, the medical community has seen similar shifts, such as the recognition of the gut microbiome and its key role in overall health.

“iCarbonX and AOBiome share a mission to enable every individual to thoroughly manage their health and prevent disease. The fact that the AOB platform is poised to be the first FDA approved host regulated drug is a breakthrough in the concept of truly personalized medicine. That kind of groundbreaking work in biotechnology is at the heart of iCarbonX and its core values,” said Wang. BTIG served as a financial advisor to AOBiome during its fundraising efforts.

About AOBiome
AOBiome is a Boston and San Francisco based biotech company focused on transforming human health through products that restore ammonia oxidizing bacteria (AOBs) to the body, which current hygiene practices have stripped from the modern human microbiome. Founded in 2013 by Patients Like Me founder Jamie Heywood and MIT Chemical Engineer David Whitlock the company is developing a novel class of therapeutics to improve skin health, hypertension, and other systemic conditions. AOBs convert ammonia to nitrite, an anti-microbial compound, and nitric oxide, a well-documented signaling molecule in the inflammatory process. AOBiome also owns the Mother Dirt branded line of consumer biome-friendly products targeted at restoring and maintaining the delicate balance of the skin biome. Learn more at AOBiome.com. 

 

More Than 150M People Affected by Hypertension in the US Could Benefit From Patented AOB Treatment

Leading microbiome company AOBiome announced today the launch of its Phase 2 clinical trial using its first-in-class live bacteria (B244) for the treatment of hypertension. This is the second indication for AOBiome’s novel ammonia oxidizing bacteria following the enrollment of patients in its acne vulgaris trial earlier this fall. Once deployed on the skin, AOBiome’s proprietary ammonia oxidizing bacteria (AOBs) produce nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

AOBiome is exploring hypertension following the discovery of a correlation between the application of AOBs and blood pressure during AOBiome’s recent Phase 1B/2A acne study, for which blood pressure was tracked as a safety endpoint. Subsequent to this discovery, the company has brought on blood pressure experts to verify the B244 bacteria’s mechanism of action as it relates to the vascular system.

“In the two week, placebo-controlled safety study of the topical application of B244 bacterial mist on the face, we observed a dose-dependent reduction in blood pressure in normotensive subjects. The effect reached statistical significance at the highest treatment dose,” said Dr. Larry Weiss, Chief Medical Officer of AOBiome. “This study provides early insight into the potential that repopulating the microbiome with ammonia oxidizing bacteria has to treat disease and improve health.”

The Phase 2 hypertension study marks the advancement from the company’s successful acne vulgaris trial, which resulted in no serious adverse events, and no difference in adverse events between treatment and vehicle groups. Partnering with Veristat, the company will enroll 116 patients in a 28-day, double blind, placebo-controlled trial for the treatment of hypertensive patients.

“We have long postulated that delivering nitric oxide in host mediated environment would regulate blood pressure, but until the discovery of this bacteria, this has proven to be extremely difficult to achieve. This exciting breakthrough potentially provides us with a new modality of treatment for patients with pre-hypertension and the ability to improve blood pressure control in hypertensive patients without adversely impacting patient lives,” said hypertension specialist, Dr. Joel Neutel, who has performed over 500 blood pressure studies.

The company is advancing a new Germ Theory of Health by reintroducing ancestral keystone commensal bacteria to our body’s natural microbiome. In the last ten years, the medical community has seen similar shifts, such as the recognition of the gut microbiome and its key role in overall health.

“Moving beyond dermal indications is an important step for AOBiome to show the breadth and power of restoring evolutionary levels of nitric oxide and nitrite to the entire system. There will be additional systemic clinical targets to come as we continue to follow the anti-inflammatory properties of our bacterial platform,” said Todd Krueger, President of AOBiome.

According to the CDC, there are 75 million patients currently being treated for hypertension and another 75 million pre-hypertensive patients in the United States who are hesitant to start blood pressure therapy due to the adverse effects of the current slate of antihypertensive medications. B244’s safety record and quick response profile makes this an ideal product to address this massive market. The company expects the FDA Phase 2 study to be completed before the end of 2017.

About AOBiome
AOBiome is a Boston and San Francisco based biotech company focused on transforming human health through products that restore ammonia-oxidizing bacteria (AOBs) which current hygiene practices have stripped from the modern microbiome. Founded in 2013 by MIT Chemical Engineer David Whitlock and Patients Like Me founder Jamie Heywood, the company is developing a novel class of therapeutics to improve skin health, hypertension, and other systemic conditions. AOBs convert ammonia to nitrite, an anti-microbial compound, and nitric oxide, a well-documented signaling molecule in the inflammatory process. AOBiome also owns the Mother Dirt branded line of consumer biome-friendly products targeted at restoring and maintaining the delicate balance of the skin biome. Learn more at AOBiome.com. 

Phase 2B Trial to Use Smartphones to Acquire Data with Partner Science37

Leading skin microbiome company AOBiome announced today the launch of its Phase 2B trial using its first-in-class live bacteria to treat acne. Phase 2B marks the advancement from the company’s successful Phase 1B/2A dose-ranging safety study, which resulted in no serious adverse events and no difference in adverse events between treatment and vehicle groups. The Phase 2B trial is being jointly conducted with Science 37, a clinical research organization applying breakthrough telemedicine-based approach to bring clinical trials directly to patients’ homes. With approximately 372 adult patients enrolled for the treatment of mild-to-moderate acne vulgaris in adults with AOB, the trial will also employ smartphones for collecting real-time patient data – an industry first. The study is expected to be completed by Q3 of 2017.

“With the remarkable outcome of the Phase 1B/2A study, we are excited to see the results of this upcoming Phase 2B trial with Science37, which will feature one-to-one randomized, double-blind, and placebo controlled doses, over the course of 12 weeks. AOB’s unique safety profile allows us to reach more patients and to rapidly test for clinical efficacy across multiple disease states, with acne being the first,” says Chief Medical Officer Dr. Larry Weiss.

Acne is an inflammatory skin disease that currently affects an estimated 80 million Americans, and is the most common skin condition in the US. By treating acne with live, ammonia-oxidizing bacteria, AOBiome is setting the stage for the topical treatments and clinical trials of tomorrow. The company is advancing the conventional Germ Theory of Disease by reintroducing ancestral keystone commensal bacteria to our skin’s natural microbiome. In the last ten years, the medical community has seen similar shifts, such as the recognition of the gut microbiome and its key role in overall health.

“We are excited to align Science 37’s next generation, technologically-enabled capabilities with AOBiome’s cutting edge approach to skin health. Through this partnership, AOBiome is able to engage with a significantly wider and more diverse population faster, and more cost effectively, than traditional methods,” says Todd Krueger, President of AOBiome.

Until now, the study of acne treatments largely depends on a dermatologist’s ability to count the number of breakouts on a patient’s face in person. Pervasive skin diseases like acne are great candidates for Science 37 teledermatology-based assessment. Teledermatology has been one of the most popular applications of e-health and telemedicine to capture information and visual data from dermatology patients, while tracking progress.

“With Science 37’s technology, decentralized operating model, and clinical trials management, the process to participate in this AOBiome trial will be much easier for patients, and unlocks their access to our expert Science 37 researchers around the country,” said Dr. Noah Craft, MD, PhD cofounder and CEO of Science 37. “We are thrilled to leverage emerging technologies and strategic partnerships with companies like AOBiome, which is committed to improve the lives of our patients and to accelerate finding new cures for the people that need them most.”

With the introduction of smartphones during the Phase 2B trial, patients can safely take part no matter their location, and using medications and iPhones shipped personally to them. The study is currently enrolling acne patients from 9 U.S. states.

About AOBiome
AOBiome is a Boston and San Francisco based biotech company focused on transforming human health through products that restore ammonia oxidizing bacteria (AOBs) which current hygiene practices have stripped from the modern microbiome. Founded in 2013, the company is developing a novel class of therapeutics to improve skin health as well as other systemic conditions. AOBs convert ammonia and urea in sweat to nitrite, an anti-microbial compound, and nitric oxide, a well-documented signaling molecule in the inflammatory process. AOBiome also owns the Mother Dirtbranded line of consumer biome-friendly products targeted at restoring and maintaining the delicate balance of the skin biome. Learn more at AOBiome.

About Science 37
Science 37 is a Los Angeles based technology-enabled clinical research company. They created a new clinical trial operating model – the metasite™ – that unlocks access so researchers can find the right patients, and patients can find the right trials. Their Network Oriented Research Assistant, NORA®, is the cloud-based patient-centric mobile research platform that connects everyone – safely and securely. Science 37 offers end-to-end clinical trial services without geographic limitations, making clinical research faster to accelerate biomedical discovery in all therapeutic areas. Ultimately, Science 37 enables better, faster people-powered science and brings clinical trials to scale. Learn more at Science37.