07.03.2017 22:35

Axsome Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Business Update

Interim analysis results from two Phase 3 trials of AXS-02 in separate indications anticipated in 2H 2017Top-line results from the Phase 3 STRIDE-1 trial of AXS-05 in treatment resistant depression expected in 1Q 2018Phase 2/3 trial of AXS-05 in Alzheimer's disease agitation to begin in 2Q 2017NEW YORK, March 07, 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 fourth quarter and year ended December 31, 2016."In 2016 we advanced our late-stage portfolio resulting in three ongoing pivotal trials in three indications. We anticipate launching a potentially pivotal trial in a fourth indication, Alzheimer's disease agitation, in the second quarter of 2017," said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome."The next 12 months will be significant for Axsome as we expect results from all of our ongoing Phase 3 trials during this period. Prudent cash management has allowed us to extend our cash runway through these important clinical milestones which include an interim analysis for efficacy from the CREATE-1 trial in complex regional pain syndrome, and top-line results from the STRIDE-1 trial in treatment resistant depression. An interim analysis to assess sample size assumptions is now planned for the COAST-1 trial in knee osteoarthritis associated with bone marrow lesions, with results expected in the third quarter of 2017. We look forward to these near-term clinical results which will shed light on the potential of AXS-02 and AXS-05 in multiple indications."Pipeline UpdateAxsome 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 in two separate Phase 3 clinical programs for treatment resistant depression (TRD) and Alzheimer's disease (AD) agitation. AXS-05 utilizes Axsome's technology of combining bupropion and dextromethorphan (DM) to increase the bioavailability of DM and unlock its therapeutic potential. DM and bupropion target multiple monoaminergic and glutamatergic neurotransmitter systems that are implicated in numerous CNS disorders. Bupropion also serves to increase the bioavailability of DM.TRD: In February 2017, the U.S. Food and Drug Administration (FDA) granted Axsome Fast Track designation for AXS-05 for the treatment of TRD. Axsome is evaluating AXS-05 in the STRIDE-1 trial, 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. TRD is a serious and difficult-to-treat condition with potentially devastating consequences. STRIDE-1 is a two-period trial in which all subjects are initially being treated with bupropion in Period 1. Those failing to respond in Period 1 are then randomized to treatment with AXS-05 or bupropion in Period 2.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 the treatment of AD agitation. Agitation is reported in as many as 40% of patients with AD and has been associated with increased caregiver burden, decreased functioning, earlier nursing home placement, and death. The planned Phase 2/3 trial is a multicenter, randomized, double-blind, placebo-controlled study to examine the efficacy and safety of AXS-05 in AD patients with agitation. Eligible subjects will be randomly assigned to treatment with AXS-05, placebo, or bupropion. There are currently no therapies approved by the FDA for the treatment of agitation in patients with AD.AXS-02: Axsome is developing AXS-02 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). AXS-02 (disodium zoledronate tetrahydrate) is a potent osteoclast inhibitor being developed as an oral, targeted, non-opioid, potentially first-in-class therapeutic for chronic pain. AXS-02 is dosed once per week for 6 weeks and thereafter may have a duration of effect measured in months.CRPS: Axsome is evaluating AXS-02 in the CREATE-1 study, a Phase 3, global, randomized, double-blind, placebo-controlled 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 that will be conducted on the first approximately 95 enrolled subjects. Axsome previously received positive scientific advice from the European Medicines Agency (EMA). Based on this advice, Axsome believes the CREATE-1 trial, if successful, will be sufficient to support a marketing authorization application (MAA) to the EMA seeking European approval of AXS-02 for the treatment of pain associated with CRPS.In October 2016, Axsome announced the publication of data showing that AXS-02 inhibits pain in a well-validated animal model of CRPS. CRPS is characterized by severe, continuous, disabling limb pain, is widely considered one of the most painful conditions, and is not considered responsive to standard pain medications. There is currently no drug approved by the FDA or the EMA for this condition. AXS-02 has received Fast Track designation from the FDA, and orphan drug designation from the FDA and EMA for the treatment of CRPS.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. COAST-1 is being conducted pursuant to an FDA Special Protocol Assessment (SPA), and this program has received Fast Track designation from the FDA.An interim analysis will now be performed by an independent data monitoring committee on the first approximately 60 subjects enrolled in the trial to assess the assumptions used to determine the sample size of the study. Screening of subjects in this trial will be paused pending results of the interim analysis, and will resume after readouts from Axsome's other ongoing Phase 3 trials in CRPS and TRD. The pause in screening is ...Full story available on
Weiter zum vollständigen Artikel bei "Benzinga earnings"
Quelle: Benzinga

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