AOBiome Therapeutics has commenced a Phase II clinical study evaluating the safety, tolerability, and efficacy of its Ammonia Oxidizing Bacteria (AOB) product candidate for the treatment of episodic migraine.

The randomised, double-blind trial aims to enrol 303 patients with episodic migraine.

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As part of the trial, AOB will be delivered as an intranasal spray to patients, who will be randomised 1:1:1 in three arms including lower dose AOB, higher dose AOB, and vehicle.

The trial’s primary endpoint is safety, while the secondary endpoints include the measurement of mean change and reductions in migraine days and attacks.

"Initiation of our migraine study extends our AOB pipeline to a broad neurology indication for the first time."

The company’s AOB product candidate is a single strain of beneficial AOB, Nitrosomonaseutropha. This converts naturally occurring ammonia to nitric oxide, a signalling molecule that can regulate inflammation and vasodilation, and to nitrite, altered levels of which are linked to migraines.

AOBiome Therapeutics president and CEO Todd Krueger said: “Initiation of our migraine study extends our AOB pipeline to a broad neurology indication for the first time.

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“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.”

California Medical Clinic for Headache director David Kudrow said that migraine is estimated to be the third most common disease in the world and is claimed to be one of the top six most disabling illnesses.

Currently, limited options are available to treat migraine, with over 50% patients starting to take preventive medications stop taking them within six months either because of their ineffectiveness or non-tolerance.