This morning before U.S. markets opened, clinical-stage biopharmaceutical company Axsome Therapeutics Inc. (AXSM:NASDAQ), a developer of novel therapies for the management of central nervous system disorders, announced that "AXS-12 (reboxetine) met the prespecified primary endpoint and significantly reduced the number of cataplexy attacks as compared to placebo in patients with narcolepsy in the firm's CONCERT Phase 2 trial."
The company stated that in the trial "AXS-12 also significantly reduced excessive daytime sleepiness (EDS), and improved cognitive function, sleep quality and sleep-related symptoms." Additionally, Axsome reported that AXS-12 was safe and well tolerated and that there were no serious adverse events reported in the trial.
Professor of Neurology at Albert Einstein College of Medicine Dr. Michael J. Thorpy commented, "Narcolepsy is a neurological disorder that interferes with mental and social functioning, increases work and driving related accidents, and results in a nearly two-fold higher mortality rate...Medications that have the potential to reduce cataplexy symptoms, promote wakefulness, and enhance cognitive function, such as AXS-12, if borne out in Phase 3 trials, could provide new treatment options for patients living with this debilitating disorder."
Herriot Tabuteau, MD, CEO of Axsome, remarked, "We are very pleased with the results of the CONCERT trial, which demonstrated a strong effect of AXS-12 on both cataplexy and excessive daytime sleepiness symptoms, as well as on cognitive function, in narcolepsy patients. The improvement in the ability to concentrate with AXS-12 is especially relevant because the cognitive impairment associated with narcolepsy is one of the most distressing aspects of the disease for patients, as highlighted in the FDA's The Voice of the Patient report on Narcolepsy...Based on these positive results, Axsome intends to initiate Phase 3 trials of AXS-12 in 2020 with the goal of bringing this differentiated experimental medicine to narcolepsy patients as soon as possible."
The company's SVP of Clinical Development and Medical Affairs Cedric O'Gorman, MD, added, "The CONCERT trial exemplifies Axsome's commitment to accelerating the innovation of effective treatments for difficult-to-treat CNS disorders such as narcolepsy...Existing treatment options for narcolepsy are few, do not address all key symptoms, may not be well tolerated, and are mostly controlled substances. If successfully developed, AXS-12 may overcome these limitations and could make it a candidate as foundational therapy to meaningfully improve the lives of the many narcolepsy patients."
The company advised that the CONCERT trial was a Phase 2, double-blind, randomized study of AXS-12 in 21 patients diagnosed with narcolepsy. The firm further explained that "narcolepsy afflicts an estimated 185,000 individuals in the U.S. and is a serious and debilitating neurological condition that causes dysregulation of the sleep-wake cycle and is characterized clinically by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep."
Axsome notes that "AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor for the treatment of narcolepsy. AXS-12 modulates noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognition."
Axsome Therapeutics, headquartered in New York, is a clinical-stage biopharmaceutical company engaged in the development of novel therapies for the management of central nervous system (CNS) disorders. The firm states that its core CNS product candidate portfolio includes four clinical-stage candidates: AXS-05; AXS-07; AXS-09 and AXS-12. Ongoing studies include a phase 3 trial of AXS-05 in treatment resistant depression, a phase 3 trial in major depressive disorder, and a phase 2/3 trial in agitation associated with Alzheimer's disease. The company also has two active phase 3 trials of its AXS-07 for the acute treatment of migraine, and a phase 2 trial of AXS-12 in narcolepsy.
Axsome Therapeutics has a market cap of about $1.4 billion with approximately 34.51 million shares outstanding and a short interest of 17.3%. AXSM shares opened today at $45.13 (+$5.51, +13.91%) over yesterday's $39.62 closing price. The stock has traded between $42.34 to $47.24 per share today and currently is trading at $45.44 (+$5.82, +14.69%).
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