Microbiome startup AOBiome Therapeutics has seen positive data from its phase 2b trial in acne.
The Cambridge, MA-based biotech says its ammonia oxidizing bacteria (AOB), a first-in-class therapy, showed a statistically significant two-point reduction (p = 0.03) in acne severity compared to vehicle control across several hundred patients over a 12-week period. The study also showed “a trend in the reduction of the number of inflammatory lesions compared to control, a second primary endpoint,” the company added in a statement.
AOBiome’s candidate is a topical formulation of a single strain of beneficial AOB, Nitrosomonas eutropha. The biotech’s AOB platform uses both a topical and intranasal of Nitrosomonas eutropha, and is designed to repopulate the skin or nasal microbiome with AOB normally found on the body. AOB is able to convert ammonia to nitrite, which has antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.
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“We are proud of the continued success and progress of our acne program,” said Todd Krueger, president of AOBiome. “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.”
“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,” added CMO Larry Weiss, M.D. “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.”
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Given the acne results, AOBiome adds that it now plans “to expand its dermatology platform to include atopic dermatitis, pruritus, and rosacea.”