Axsome Therapeutics Announces Positive Outcome of Interim Analysis of STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression
Independent Data Monitoring Committee recommends trial continuation
Second interim analysis anticipated second half of 2018 for efficacy
AXS-05 is a novel, oral, fixed-dose combination of dextromethorphan and bupropion. AXS-05 combines glutamatergic and monoaminergic mechanisms of action, which have been associated with antidepressant effects, and Axsome’s metabolic inhibition technology. Pharmacokinetic data with AXS-05 and clinical observations with the dextromethorphan component indicate that AXS-05 increases dextromethorphan concentrations into a potentially therapeutic range. AXS-05 has been granted
“The positive outcome of this interim futility analysis combined with the multiple mechanisms of action of AXS-05 support its continued development for treatment resistant depression,” said
The STRIDE-1 interim futility analysis was performed on the first approximately 40% of the target number of subjects. A second interim analysis will be performed on the first approximately 60% of the target number of subjects to assess efficacy.
“The IDMC’s recommendation for continuation of the STRIDE-1 trial and its findings of an overall favorable clinical safety profile for AXS-05 are encouraging,” said Cedric O’Gorman, MD, Senior Vice President of Clinical Development and Medical Affairs of Axsome. “A significant proportion of patients with major depressive disorder are treatment resistant, having previously failed two or more therapies. There are limited available treatment options for these patients. AXS-05’s multiple mechanisms, targeting glutamatergic, monoaminergic and anti-inflammatory pathways, may offer a unique therapeutic approach for this serious condition.”
The Company recently held a research and development (R&D) day focusing on AXS-05. Of relevance to treatment resistant depression were presentations by key opinion leaders
The R&D day also featured presentations from key opinion leaders
About the STRIDE-1 Study
STRIDE-1 (Symptom Treatment in Resistant Depression 1) is a Phase 3, randomized, double-blind, active controlled trial to assess the efficacy and safety of AXS-05 in the treatment of treatment resistant depression (TRD). Patients with major depressive disorder (MDD) who have previously failed one or two antidepressant treatments are treated in an open-label fashion with bupropion during a 6-week lead-in period. Patients who fail to respond to bupropion during this lead-in period are randomly assigned in a 1:1 ratio to receive bupropion or AXS-05 in a double-blind fashion for 6 weeks. The primary endpoint is the change in the
About Treatment Resistant Depression (TRD)
Patients diagnosed with major depressive disorder (MDD) are defined as having TRD if they have failed two or more antidepressant therapies. MDD is a serious condition characterized by depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and which impairs social, occupational, educational, or other important functioning. According to the
About AXS-05
AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 consists of bupropion and dextromethorphan and utilizes Axsome’s metabolic inhibition technology. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is an investigational drug product not approved by the
About
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the trials, futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain
Axsome Contact:
Senior Vice President, Operations
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com
Source: Axsome Therapeutics, Inc.