Published on 17 Sep 2021 on Zacks via Yahoo Finance
Axsome Therapeutics, Inc. AXSM announced that it has initiated enrollment in the phase III study — SYMPHONY — which will evaluate its pipeline candidate, AXS-12, in patients with narcolepsy, a sleep disorder. Top-line data from the study is expected in 2023.
The company has successfully completed a phase II study evaluating the candidate in narcolepsy patients. Data from the mid-stage study demonstrated that treatment with AXS-12 resulted in a highly statistically significant reduction in the mean weekly number of cataplexy attacks from baseline compared to placebo, following a treatment period of two weeks. The treatment with AXS-12 also improved excessive daytime sleepiness by reducing the frequency of inadvertent naps in patients.
The candidate enjoys Orphan Drug Designation for the treatment of narcolepsy in the United States. However, the candidate lost its Breakthrough Therapy designation in July this year. The company stated that the FDA repealed the Breakthrough Therapy designation, following its approval to another drug, most likely Harmony Biosciences’ HRMY Wakix, as the first and only non-scheduled treatment for narcolepsy patients. We note that apart from Harmony Biosciences, Axsome will also face stiff competition from Jazz Pharmaceuticals JAZZ that has a strong sleep disorder portfolio with a couple of drugs approved to treat narcolepsy.