Luye Pharma releases the first-line results of Phase II clinical trials of its new antidepressant Ansofacine Hydrochloride Sustained-Release Tablets – QNT Press Release

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Chongqing, China, December 23, 2021 /PRNewswire/-Luye Pharmaceutical Group today announced the encouraging top-line results of a Phase II clinical trial of its new antidepressant drug Ansofacine Hydrochloride Sustained-Release Tablets (LY03005).day National Psychiatry Academic Conference of Chinese Medical Association.

Overall, based on the preliminary results of phase II clinical trials, LY03005 has shown comprehensive antidepressant efficacy and good safety and tolerability. In particular, no significant adverse events related to changes in sexual function or body weight were found, and no significant increase in sleepiness was observed.

LY03005 is a new chemical entity (NCE) with a novel mechanism of action. 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) stage China.

The first-line results announced this time come from a multi-center, randomized, double-blind, placebo-controlled Phase II study, which aims to initially evaluate the efficacy and safety of LY03005 in the treatment of major depressive disorder (MDD), and to explore the optimal dose. 260 MDD patients participated in the study and were randomly assigned to receive LY03005 (dose of 40 mg, 80 mg, 120 mg, and 160 mg) or placebo for 6 weeks. The main findings are as follows:

  • LY03005 reached the primary endpoint and showed a good remission rate and remission rate.

The primary endpoint results showed that the change in the total score of the 17-item Hamilton Depression Scale (HAM-D17) from baseline showed that all LY03005 administration groups were treated in 6-weeks compared with the placebo group.

For secondary endpoints, LY03005 was better than placebo in the changes in the total Montgomery-Osberg Depression Rating Scale (MADRS) scores from baseline and the changes in CGI​​-I scores of all drug groups for 6 weeks , The difference was statistically significant (P<0.05 and P<0.1, respectively); CGI-S score changes in the LY0300 540mg, 80mg, and 160mg administration groups were better than placebo, the difference was statistically significant (P<0.05); In addition, LY03005 The response rate based on MADRS for the 80mg and 160mg administration groups (the total MADRS score is reduced by ≥50% from the baseline) is 68% and 71%, respectively, and the remission rate (the total MADRS score is based on the two administration groups of MADRS ≤ 12), respectively It was 60% and 56%, which also showed a statistically significant difference (P<0.1).

  • LY03005 shows the potential to improve symptoms such as anxiety and cognitive impairment

For the secondary endpoint, LY03005 is at 40 mg,…

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