Once New York-based Axsome Therapeutics, Inc. (NASDAQ: AXSM) was founded in 2012, its team set out to establish a fully-integrated biopharmaceutical business that would develop therapies to treat and manage central nervous system (CNS) disorders. Now in 2017, the Axsome team is setting off on another exciting leg on this journey.
For years, Axsome has been laser-focused on improving the lives of patients living with pain and various CNS disorders. With an eye toward differentiated therapies, the company has concentrated on developing and commercializing both in-licensed drug candidates and internally-derived drug candidates in order to accomplish its goal of increasing the treatment options accessible to caregivers.
Along the way, industry analysts have pointed out the value in Axsome’s focus on complex regional pain syndrome, treatment resistant depression and agitation in patients with Alzheimer’s disease (AD); the lower-than-average research and development risks, as well as the tested business models that surround these disorders, hint at a faster commercialization schedule.
During the first week of 2017, a new report from AEGIS Capital Corp. (http://dtn.fm/w6MIe) also alluded to Axsome’s accelerated timeline and other investment highlights, including recent developments affecting one of the company’s two late-stage drug candidates: AXS-05, a fixed-dose combination of dextromethorphan and bupropion that is being developed for multiple indications, including treatment resistant depression and agitation in patients with AD.
According to the AEGIS report, on January 4, 2017, Axsome announced that the United States’ Food and Drug Administration (FDA) had cleared its Investigational New Drug (IND) application for a phase II/III clinical trial of AXS-05 in AD. This is a significant development for the company, as this IND program is the means by which a pharmaceutical company operating within the United States obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. With the FDA’s approval in tow, the placebo-controlled, randomized, double-blind, multicenter trial is now set to register the necessary 330 patients and to commence sometime in the first half of 2017.
To learn more, visit www.Axsome.com
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