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.
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.
SOURCE AOBiome Therapeutics