Luye Pharma's new antidepressant drug Ansufaxine Hydrochloride Sustained-Release Tablets Phase II Clinical Data Released

Overall: LY03005 has initially shown a comprehensive antidepressant effect in the exploratory study of phase II clinical trials, and has good safety and tolerability, especially on sexual function, weight, and lethargy
.

LY03005 is a new molecular entity therapeutic drug with a brand-new mechanism of action.
It is a potential triple reuptake inhibitor (SNDRI/TRI) of serotonin (5-HT), norepinephrine (NE) and dopamine (DA).
Completed Phase I to Phase III clinical trials in China and is in the stage of market application
.

The phase II clinical trial data released this time comes from a multi-center, randomized, double-blind, placebo-controlled study to initially evaluate the effectiveness and safety of LY03005 in the treatment of depression, and to explore the optimal dosage
.

· LY03005 reaches the main efficacy endpoint, and has a good effective rate and remission rate

The primary efficacy endpoint showed that the total scores of the 17 Hamilton Depression Rating Scale (HAM-D17) in each dose group of LY03005 at the end of the 6th week were better than those of the placebo group, and the difference was statistically significant (P<0.
05)
.

Among the secondary efficacy endpoints: the Montgomery-Asperger Depression Scale (MADRS) total score at the end of the 6th week compared with baseline changes, CGI-I score changes, each dose group of LY03005 was significantly better than placebo, the difference was statistically significant ( Respectively P<0.
05, P<0.
1); CGI-S score changes at the end of the 6th week, the 40mg, 80mg, and 160mg dose groups of LY03005 were better than placebo, and the difference was statistically significant (P<0.
05); in addition, compared with placebo Compared with the 80mg and 160mg dose groups of LY03005, the effective rate of MADRS (reduction value ≥50% from baseline) reached 68% and 71%, respectively, and the MADRS remission rate (MADRS≤12) of the two dose groups reached 60%.
%, 56%, the difference is statistically significant (P<0.
1)
.

·  LY03005 has potential in improving symptoms such as anxiety and cognitive impairment

Among the secondary efficacy endpoints: Hamilton Anxiety Scale (HAM-A) total scores, HAM-A somatic anxiety factor scores, and HAM-D17 anxiety/somatization factors in the 40 mg, 80 mg, and 160 mg dose groups of LY03005 are better than placebo The difference between the groups was statistically significant (P<0.
1); in addition, the HAM-A mental anxiety factor and HAM-D17 cognitive impairment factor in all dose groups had a downward trend compared with the baseline
.

·  LY03005 is safe and well tolerated, especially has no significant effect on sexual function, weight, and lethargy

The safety data suggest that LY03005 has good safety and tolerability.
The adverse reactions are mostly mild or moderate, and the duration is short, which rarely leads to the termination of treatment; the Arizona Sexual Experience Scale (ASEX) score results show: LY03005 and There was no difference between placebo, and no adverse reaction reports of sexual dysfunction were seen in the trial; there were only 3 cases of weight changes judged to be related to or possibly related to the study drug in the trial, all of which were mild and moderate, and all were relieved at the end of treatment; The LY03005 dose group was similar to the placebo group in the incidence of lethargy
.

Comprehensive antidepressant efficacy and good safety and tolerance can help patients achieve true recovery

The main investigator of the Phase II clinical trial of LY03005 and Professor Zhang Hongyan from Peking University Sixth Hospital pointed out: "The clinical efficacy characteristics displayed by LY03005 can help patients comprehensively improve depressive symptoms, improve functional impairment, and achieve the goal of clinical cure; this drug The safety advantage of ”is more conducive to the standard treatment of patients throughout the course of the disease, and is expected to help them return to society
.

The main clinical manifestations of depression are core symptoms such as low mood and lack of energy, as well as accompanying symptoms such as cognitive decline and decreased sexual function
.

In addition, poor patient compliance is another important factor affecting the prognosis of depression
.

"LY03005 is developed in accordance with the 5-HT/NE/DA triple reuptake inhibitor treatment concept, and is committed to solving the current unmet needs of patients, including the impairment of social function and long-term drug intolerance
.

In addition to China, LY03005 is currently still in the new drug application stage in the United States, and phase I clinical trials have been completed in Japan