Axsome Therapeutics, Inc. AXSM announced that the phase II study – CONCERT – evaluating its pipeline candidate, AXS-12 (reboxetine), met the pre-specified primary endpoint. The study evaluated AXS-12 as a treatment for narcolepsy patients with cataplexy, a sleep disorder characterized by excessive sleepiness.
Data from the study showed that patients treated with AXS-12 achieved a statistically significant reduction in mean weekly cataplexy attacks over a treatment period of 2 weeks.
Shares of Axsome rose more than 15% on Dec 3, following the positive top-line data readout. The company’s shares have skyrocketed 1517.4% so far this year compared with the
industry’s rise of 4.6%.
Data from the CONCERT study showed that mean reductions in weekly cataplexy attacks from baseline was 48.8% in the AXS-12 arm versus 8.6% in the placebo arm. Moreover, 76.2% patients achieved 50% or more reduction in the weekly number of cataplexy attacks following treatment with AXS-12, compared to 30% for placebo. Treatment with AXS-12 also demonstrated rapid improvement in cataplexy attacks, as early as the first week of treatment, which marked a significant benefit over placebo.
Treatment with AXS-12 also achieved reduction in excessive daytime sleepiness improved cognitive function and sleep quality compared to placebo. The candidate was also safe and well tolerated with no serious adverse events reported in the trial and no discontinuations due to adverse events.
Based on these positive data from the phase II study, Axsome plans to initiate a phase III study to evaluate AXs-12 in narcolepsy patients in 2020. The candidate enjoys Orphan Drug Designation in the United States for the treatment of narcolepsy.
We note that shares of Jazz Pharmaceuticals (
JAZZ Quick Quote JAZZ - Free Report) , which holds a strong position in the sleep disorder segment, were down 2.6% on Dec 3. The company’s blockbuster drug, Xyrem, is approved for both cataplexy and excessive daytime sleepiness. Although AXS-12 is a few years away from commercialization, it will likely face stiff competition from Xyrem. Other drugs available for the treatment of narcolepsy include Jazz’s Sunosi, Teva Pharma’s TEVA Provigil and Novartis’ NVS Ritalin-SR.
Apart from AXS-12, Axsome has several candidates targeting central nervous system disorder including AXS-05, AXS-07 and AXS-09. The company’s most advanced candidate, AXS-05, is being developed in a phase III study as a treatment for major depressive disorder. In April, the company’s phase II study, evaluating AXS-05 for the smoking cessation treatment, met its pre-specified primary endpoint of significantly curbing the habit of daily smoking.
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