Axsome Therapeutics, Inc. (NASDAQ: AXSM) rose Monday after reporting positive outcome of interim analysis for the ADVANCE-1 Phase 2/3 trial of AXS-05 in agitation associated with Alzheimer’s disease.
Based on the results of the analysis, the IDMC recommended continuation of the AXS-05 treatment arm. Additionally, the IDMC recommended no further randomization of subjects to the bupropion treatment arm of the study. The IDMC did not indicate that there were any safety concerns in the study. Axsome intends to follow the IDMC’s recommendations.
AXS-05 is a novel, oral, investigational medicine consisting of dextromethorphan and bupropion.
Patients in the ADVANCE-1 trial were being randomized in a 1:1:1 ratio to treatment with AXS-05, placebo, or bupropion.
Said Chief Medical Officer Herriot Tabuteau, "We are pleased that further enrollment to the bupropion single-agent arm is no longer deemed necessary. Inclusion of that arm was driven by the FDA’s guidelines to examine contribution of the individual components of product candidates like AXS-05 that contain two active agents.
"We anticipate that implementation of the IDMC’s recommendations may provide greater flexibility to our operating plans and timelines which we will evaluate in the coming weeks. We will continue to be rigorous with our oversight of the conduct of the study."
New York-based Axsome Therapeutics. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system disorders for which there are limited treatment options.
Shares in the stock climbed 45 cents, or 15.3%, to $3.40.
