Luye Pharma Group today 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.
In general, LY03005 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. The main findings are as follows:
LY03005 reached the primary endpoint, showing a good response rate and remission rate.
Primary endpoint results show that the change of the 17-item Hamilton Depression Rating Scale (HAM-D17) total score from the baseline displayed a difference of statistical significance (P<0.05) for all dosing groups of LY03005 compared with the placebo after the 6-week treatment.
For the secondary endpoints, LY03005 was superior to the placebo for all dosing groups in terms of both the change of the total score on the Montgomery–Åsberg Depression Rating Scale (MADRS) from the baseline and the change of the CGI-I score after the 6-week treatment, displaying a difference of statistical significance (P<0.05 and P<0.1 respectively); LY03005 was superior to the placebo for the dosing groups of 40 mg, 80 mg, and 160 mg in terms of the change of the CGI-S score, displaying a difference of statistical significance (P<0.05); in addition, the response rate (the reduction of MADRS total score from the baseline ≥50%) of LY03005 based on MADRS for the 80 mg and 160 mg dosing groups was 68% and 71% respectively, and the remission rate (MADRS total score ≤12) of these two dosing groups based on MADRS was 60% and 56% respectively, also displaying a difference of statistical significance (P<0.1).
LY03005 showed potential for improving symptoms such as anxiety and cognitive disorders
For the secondary endpoints, LY03005 was superior to the placebo for the dosing groups of 40 mg, 80 mg, and 160 mg in terms of the total HAM-A score, the HAM-A Somatic Anxiety Factor score, and the HAM-D17 Anxiety/Somatization Factor score, displaying a difference of statistical significance (P<0.1). In addition, the HAM-A Psychic Anxiety Factor score and the HAM-D17 Cognitive Dysfunction Factor score demonstrated a trend of declining from the baseline for all dosing groups.
LY03005 showed a good safety profile and tolerance, with no significant adverse effects on sexual functioning, weight, or sleep
The safety data shows: 1) LY03005 demonstrated a good safety profile and tolerance, and most of the adverse events were mild or moderate with a short duration, seldom resulting in the termination of treatment; 2) there was no significant difference between LY03005 and the placebo in terms of the Arizona Sexual Experiences Scale (ASEX) score, and no sexual dysfunction as an adverse event was found in the study; 3) only three cases of weight change were determined to be related to or possibly related to the drug used in the study, and all of the three cases were mild or moderate, showing recovery at the end of treatment; 4) LY03005 was similar to the placebo in terms of the incidence of somnolence.
A complete recovery for patients is only possible when the drug used for treating them is safe and tolerable...
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