Luye Pharma Group recently released the encouraging top-line results from a Phase II clinical trial of its new antidepressant, Ansofaxine Hydrochloride Extended-Release Tablets (LY03005), at the 19th National Psychiatry Conference of the Chinese Medical Association.
LY03005 reportedly demonstrated a comprehensive antidepressant efficacy as well as a good safety profile and tolerance based on the initial results of the Phase II clinical trial. In particular, no significant adverse events were found related to sexual function or weight change, and no significant increase of somnolence was observed.
LY03005 is a New Chemical Entity (NCE) with a novel acting mechanism. It is a potential Serotonin-Norepinephrine-Dopamine Reuptake Inhibitor (SNDRI/TRI). The drug has completed Phase I to Phase III clinical trials and is currently in the New Drug Application (NDA) phase in China.
The top-line results released this time are from a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to preliminarily evaluate the efficacy and safety of LY03005 in treating Major Depressive Disorder (MDD) and explore the optimal dosing. 260 MDD patients were enrolled in the study and randomly assigned to receive the treatment with LY03005 (at doses of 40 mg, 80 mg, 120 mg, and 160 mg) or a placebo for 6 weeks.