CAMBRIDGE, Mass., Dec. 16, 2016 /PRNewswire/ -- 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 a host-mediated environment would regulate blood pressure, but, until the discovery of this bacteria, it has proven to be extremely difficult to achieve," said hypertension specialist, Dr. Joel Neutel, who has performed over 500 blood pressure studies. "This exciting breakthrough potentially provides us with a new modality of treatment for patients with pre-hypertension, as well as the ability to improve blood pressure control in hypertensive patients without adversely impacting patient lives."
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 10 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," said Todd Krueger, President of AOBiome. "There will be additional systemic clinical targets to come as we continue to follow the anti-inflammatory properties of our bacterial platform."
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 to complete the FDA Phase 2 study before the end of 2017.
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.
Contact: Tim McGeever, [email protected], 718-887-1062.