Biopharmaceutical company Axsome Therapeutics Inc. (AXSM:NASDAQ), which is focused on developing new medicines for use in the treatment of central nervous system (CNS) disorders, today announced that "AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary and key secondary endpoints in the ACCORD (Assessing Clinical Outcomes in Alzheimer's Disease Agitation) Phase 3 trial, by substantially and statistically significantly delaying the time to relapse and preventing relapse of agitation in patients with Alzheimer's disease, as compared to placebo."
The company advised that the multi-center, randomized Phase 3 ACCORD study included a total of 178 patients in the U.S. who were diagnosed with Alzheimer's disease agitation. The firm indicated that those who had received open-label treatment with AXS-05 demonstrated "rapid, substantial, and statistically significant improvement compared to baseline in agitation symptoms." These patients who had experienced a sustained clinical response after open-label treatment with AXS-05 were then randomized to receive continued treatment with AXS-05 or a placebo.
Axsome Therapeutics noted that in the ACCORD study, AXS-05 met the primary objective defined as a substantial and statistically significant delay in the time elapsed to relapse of agitation symptoms compared to placebo. In the study, AXS-05 also met a key secondary endpoint which was listed as the prevention of relapses.
The company highlighted using the modified Alzheimer's Disease Cooperative Study-CGIC (clinicians) scale, AXS-05 was shown to lessen Alzheimer's disease agitation in 66% of patients after two weeks and by 86% of patients after five weeks. Similarly, utilizing the PGI-C assessment (caregivers) scale, 68% of patients showed improvement in agitation at two weeks, and 89% registered improvement at five weeks.
Dr. Cummings continued, "The results of the ACCORD trial demonstrate convincing clinical activity for AXS-05 on agitation associated with Alzheimer's disease based on both a significant delay in symptom relapse as well as a reduction of relapse compared to placebo."
Jeffrey Cummings, M.D., D.Sc., Director Emeritus of the Cleveland Clinic Lou Ruvo Center for Brain Health, and Chambers Professor of Brain Science at the University of Nevada Las Vegas, noted that "Agitation is one of the most troubling and consequential aspects of Alzheimer's disease for patients and their caregivers as it is associated with early nursing home placement, accelerated cognitive decline, and increased mortality."
Dr. Cummings continued, "The results of the ACCORD trial demonstrate convincing clinical activity for AXS-05 on agitation associated with Alzheimer's disease based on both a significant delay in symptom relapse as well as a reduction of relapse compared to placebo. Treatment with AXS-05 during the open-label period in a large cohort of patients resulted in rapid and clinically meaningful improvements in Alzheimer's disease agitation."
The company's CEO, Herriot Tabuteau, M.D., stated, "With the positive results from ACCORD, AXS-05 has now demonstrated efficacy in the treatment of Alzheimer's disease agitation in two well-controlled trials. In addition to the strong results versus placebo in the double-blind period, results from the open-label period evidenced rapid, substantial, and significant improvements in Alzheimer's disease agitation versus baseline with AXS-05 treatment."
"We intend to discuss these findings with the FDA in the context of the ongoing clinical development of AXS-05 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimer's disease agitation and their caregivers," Dr. Tabuteau added.
The company stated that "Alzheimer's disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline and behavioral and psychological symptoms including agitation." AD affects around six million people in the U.S. and is the most frequently occurring type of dementia. Agitation, which includes aggressive behavior, disinhibition, disruptive irritability, and emotional distress, is reported in about 70% of patients diagnosed with AD. Currently, there are no U.S. Food and Drug Administration (FDA) approved therapies to treat agitation in AD patients.
The firm explained that "AXS-05 (dextromethorphan-bupropion) is a novel, oral, patent protected, investigational N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity under development for the treatment of Alzheimer's disease (AD) agitation and other central nervous system (CNS) disorders." The company uses its metabolic inhibition technology to modulate the delivery of AXS-05's patented formulation of dextromethorphan and bupropion. The report listed that supported by the positive results collected during the ADVANCE-1 trial, AXS-05 was awarded Breakthrough Therapy designation by the FDA in June 2020 for the treatment of Alzheimer's disease agitation.
Axsome Therapeutics is a biopharmaceutical firm headquartered in New York, NY that is working to develop novel therapies for treating central nervous system (CNS) conditions. Axsome's ongoing product development pipeline includes potential treatments for agitation associated with Alzheimer's disease, acute migraine, fibromyalgia, smoking cessation, cataplexy in narcolepsy, and attention deficit hyperactivity disorder.
Axsome Therapeutics started the day with a market cap of around US$2.47 billion, with approximately 43.43 million shares outstanding and a short interest of about 15.6%. AXSM shares opened 25% higher today at US$71.035 (+US$14.215, +25.02%) over Friday's US$56.82 closing price and reached a new 52-week high price this morning of US$79.68. The stock traded today between US$68.12 and US$79.68 per share and closed for trading at US$74.68 (+US$17.92, +31.54%).
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