Interim analyses of STRIDE-1 and ADVANCE-1 trials of AXS-05 anticipated in 2018Company to host conference call today at 8:00 AM EasternNEW YORK, March 07, 2018 (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, 2017."In 2017 we significantly expanded our pipeline and now have five CNS product candidates which are in or are about to enter late-stage clinical trials in five different indications. We continued this momentum into 2018 with the recent announcement of our AXS-09 product candidate, which incorporates chirally pure esbupropion and dextromethorphan," said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. "In 2018 we are focused on the advancement of our ongoing registration trials of AXS-05, STRIDE-1 for treatment resistant depression and ADVANCE-1 for agitation associated with Alzheimer's disease, and on the launch of our planned Phase 3 trial of AXS-07 for migraine. Importantly, we have now incorporated two interim analyses into both the STRIDE-1 and ADVANCE-1 trials. In each trial, the first interim analysis will be to assess futility and the second will be to assess efficacy. Because these analyses could result in stopping the trials early for efficacy or futility, they provide the possibility for accelerated value creation and represent continued prudent capital resource management. We anticipate both STRIDE-1 interim analyses and the first ADVANCE-1 interim analysis this year." Pipeline UpdateAxsome is developing a portfolio of differentiated, patent-protected, central nervous system (CNS) product candidates. CNS disorders are underserved, difficult-to-treat, distressing to patients and caregivers, with many having no approved or satisfactory treatment options. 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 currently includes five clinical-stage product candidates.AXS-05: Axsome is evaluating AXS-05 (bupropion and dextromethorphan) in three separate indications: treatment resistant depression (TRD), agitation associated with Alzheimer's disease (AD), and smoking cessation. AXS-05 is a novel, oral, fixed-dose combination of dextromethorphan (an NMDA receptor antagonist, sigma-1 receptor agonist, and serotonin and norepinephrine reuptake inhibitor) and bupropion (a norepinephrine and dopamine reuptake inhibitor, which also increases the bioavailability of dextromethorphan), under development for the treatment of CNS disorders. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Fast Track designations for the treatment of TRD and for the treatment of agitation associated with AD.TRD: Axsome is actively 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.Two interim analyses, to be conducted by an independent data monitoring committee (IDMC), are now planned for the STRIDE-1 study. The first interim analysis will be performed on the first approximately 40% of the target number of subjects to assess futility. The second interim analysis will be performed on the first approximately 60% of the target number of subjects to assess efficacy. To date over 40% of the target number of subjects have been randomized. Therefore the results of the first interim analysis are expected in the second quarter of 2018.Agitation associated with AD: Axsome is actively enrolling the ADVANCE-1 study, a Phase 2/3, multicenter, randomized, double-blind, controlled trial to evaluate the efficacy and safety of AXS-05 in patients with agitation associated with AD.ADVANCE-1 incorporates two interim analyses to be performed by an IDMC. The first interim analysis will be performed on the first approximately 30% of the target number of subjects to assess futility. The second interim analysis will be performed on the first approximately 60% of the target number of subjects to assess efficacy. Results of the first interim analysis are expected in the second half of 2018.Smoking Cessation: In December 2017, Axsome entered into a research collaboration with Duke University to evaluate AXS-05 in a Phase 2 clinical trial in smokers attempting to quit. The planned study will be a randomized, double-blind, controlled trial evaluating the impact of AXS-05 on smoking behavior, and will be conducted at the Duke Center for Smoking Cessation. Initiation of this trial is anticipated in the first half of 2018.AXS-09: In February 2018, Axsome announced positive topline results from a Phase 1 pharmacokinetic study of AXS-09 (esbupropion and dextromethorphan), which is being developed for the treatment of CNS disorders. AXS-09 contains the chirally pure S-enantiomer of bupropion, as compared to Axsome's first generation product candidate AXS-05 (bupropion and dextromethorphan), which contains racemic bupropion (equal amounts of the S- and R-enantiomers). AXS-09 resulted in substantial increases in dextromethorphan plasma concentrations, the trial's primary endpoint, into a potentially therapeutic range with repeated dosing (p<0.0001 day 1 versus day 8). The increased plasma concentrations of dextromethorphan after dosing with AXS-09 were comparable to those achieved with AXS-05 (bupropion and dextromethorphan). Results of this Phase 1 trial coupled with preclinical data also indicate the potential for enhanced absorption and therapeutic effect of the S-enantiomer as compared to the R-enantiomer. AXS-09 was well tolerated with no serious adverse events reported in the trial. AXS-09 provides Axsome with another attractive product candidate that warrants evaluation in future CNS indications.AXS-07: Axsome is developing AXS-07 for the acute treatment of migraine. AXS-07 is an oral, fixed-dose combination of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome's MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. Rizatriptan has demonstrated strong efficacy in the treatment of migraine as a single agent. The distinct mechanism of action and rapid absorption of MoSEIC meloxicam, combined with the known efficacy of rizatriptan, is expected to result in rapid, superior and consistent relief of migraine pain, with lower symptom recurrence, as compared to currently available therapies.Axsome has received Pre-Investigational New Drug Application (Pre-IND) written guidance from the FDA on a proposed clinical developmental program for AXS-07 including a planned Phase 3 trial. Based on this guidance, Axsome believes that only one Phase 3 trial may be needed for the approval of AXS-07 for the treatment of migraine. Axsome anticipates starting this trial in 2018.AXS-02: Axsome is developing AXS-02 (disodium zoledronate tetrahydrate) in two separate indications: knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), and chronic low back pain (CLBP) associated with Modic changes (MCs). AXS-02 was also being developed in complex regional pain syndrome (CRPS). AXS-02 is a potent osteoclast inhibitor being developed as an oral, non-opioid, targeted, potentially first-in-class therapeutic for chronic pain. AXS-02 has been granted FDA Fast Track designation for the treatment of knee OA associated with BMLs.Knee OA associated with BMLs: In January 2018, an interim analysis for efficacy in the Phase 3 COAST-1 trial of AXS-02 for the treatment of the pain of knee OA ...Full story available on Benzinga.comWeiter zum vollständigen Artikel bei "Benzinga earnings"