Axsome Therapeutics Inc (NASDAQ: AXSM) rose after the company disclosed positive topline clinical trial results from a Phase 1 pharmacokinetic study of AXS-09.
The New York-based Axsome, a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive topline clinical trial results from a Phase 1 pharmacokinetic study of AXS-09, a novel, oral medicine consisting of esbupropion and dextromethorphan being developed for the treatment of CNS disorders.
A news release Monday said AXS-09 is enabled by Axsome’s technical success at isolating chirally pure and chemically stable single enantiomers of bupropion, and formulating them into dosage forms that maintain their chirality. Enantiomers are molecules which are identical in chemical structure but which differ in the three-dimensional arrangement of the atoms (i.e. mirror images).
Based on the results of this Phase 1 trial and pre-clinical data, Axsome believes that the individual enantiomers of bupropion (R-bupropion and S-bupropion) may each have unique properties that render them potentially useful in different indications.
To Axsome’s knowledge, this is the first time that stable, chirally pure single enantiomers of bupropion have been successfully formulated and dosed in a clinical trial.
Said Senior Vice-President Cedric O’Gorman "We are actively progressing AXS-05 in our ongoing Phase 3 trial in treatment resistant depression and Phase 2/3 trial in agitation in patients with Alzheimer’s disease, and we look forward to the results of those trials.
"Based on the positive Phase 1 results, AXS-09 provides us with another attractive product candidate that merits evaluation in future CNS indications.”
Shares in the company gained four cents, or 1.5%, to $2.64.
