NEW YORK, May 09, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the quarter ended March 31, 2017.
“In the first quarter we continued to advance all of our clinical programs, which include three ongoing Phase 3 trials with our lead product candidates AXS-02 and AXS-05,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. “The recently completed common stock offering bolsters our balance sheet and provides the financial resources to maintain our pipeline momentum.”
Pipeline Update
Axsome is developing a portfolio of differentiated, patent-protected, CNS product candidates. CNS disorders are distressing, difficult-to-treat, and underserved with many having no approved or satisfactory treatments. Axsome accelerates the development of new CNS medicines in a cost-efficient manner, by utilizing novel mechanisms of action and novel delivery approaches of well-characterized molecules, combined with human proof-of-concept data and innovative clinical trial designs. Our pipeline includes two late-stage product candidates in Phase 3 development and preclinical candidates.
- AXS-05: Axsome is developing AXS-05 (bupropion and dextromethorphan fixed-dose combination) in two separate Phase 3 clinical programs for treatment resistant depression (TRD) and Alzheimer’s disease (AD) agitation.
TRD: In February 2017, the U.S. Food and Drug Administration (FDA) granted Axsome Fast Track designation for AXS-05 for TRD. Axsome is enrolling the STRIDE-1 study, a Phase 3, multicenter, randomized, double-blind, active-controlled trial to assess the efficacy and safety of AXS-05 in TRD, defined as major depressive disorder which has failed to respond to two or more antidepressant treatments.
AD Agitation: In May 2017, the FDA granted Axsome Fast Track designation for AXS-05 for the treatment of AD agitation. In January 2017, Axsome received Investigational New Drug Application (IND) clearance from the FDA to proceed with a Phase 2/3 trial of AXS-05 in this indication. Axsome anticipates commencing this trial in the second quarter of 2017. - AXS-02: Axsome is developing AXS-02 (disodium zoledronate tetrahydrate) in three separate Phase 3 clinical programs: complex regional pain syndrome (CRPS), knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), and chronic low back pain (CLBP) associated with Modic changes (MCs).
CRPS: Axsome is enrolling the CREATE-1 study, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of AXS-02 in the treatment of pain in patients with CRPS. CREATE-1 incorporates an interim analysis for efficacy which will be conducted on the first approximately 95 enrolled subjects.
Knee OA associated with BMLs: Axsome is evaluating AXS-02 in the COAST-1 study, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of AXS-02 in the treatment of the pain of knee OA associated with BMLs. Screening of subjects in this trial is paused pending results of the interim analysis on the first approximately 60 subjects enrolled in the trial to assess the assumptions used to determine the sample size of the study.
CLBP associated with MCs: In February 2017, Axsome received IND clearance from the FDA to proceed with a Phase 3 trial of AXS-02 in the treatment of CLBP associated with MCs. The start of this trial is planned following readouts from Axsome’s ongoing Phase 3 trials in CRPS and TRD. - Other Programs: Axsome is currently evaluating additional product candidates, including AXS-06, that it intends to develop for CNS disorders, including chronic pain.
Corporate Update
