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Phase III Clinical Trial Results of Luye Pharma’s Investigational Drug LY03005 Presented at the 2022 APA Annual Meeting

2022 / 06 / 09 Publisher:Luye Life Sciences Group

The Phase III clinical trial results of Luye Pharma’s investigational drug LY03005, designated as a “Class 1 Chemical Drug” in China, were presented at the 2022 Annual Meeting of the American Psychiatric Association (APA), June 7-10.

APA is the largest psychiatric association in the world. The APA annual meeting is one of the top academic events for psychiatry in the world, presenting breakthrough psychiatric findings and clinical advancements, and addressing hot topics in psychiatry. Presenting the Phase III clinical trial data of LY03005 at this year’s APA annual meeting is a major step forward in the effort to gain international exposure for LY03005, an investigational drug from China for treating Major Depressive Disorder (MDD).

LY03005 with a novel acting mechanism demonstrated strong efficacy and a good safety profile

LY03005 is a New Chemical Entity (NCE) with a novel acting mechanism. Phase I to Phase III clinical trials have been completed for the drug, and it is currently in the pre-registration stage in China. As a serotonin (5-HT)-norepinephrine (NE)-dopamine (DA) reuptake inhibitor (SNDRI), LY03005 is found to be able to comprehensively and stably improve depressive symptoms, including rapidly reducing anxiety, significantly relieving anhedonia, and improving cognition. It has no significant impacts on drowsiness, sexual functioning, bodyweight and lipid metabolism. These clinical outcomes facilitate the social recovery of MDD patients. LY03005 is the world's first investigational drug for treating MDD based on an SNDRI, with its efficacy having been demonstrated by both lab research and confirmatory clinical studies. It is also China’s first Class 1 Chemical Drug for MDD with satisfactory Phase III clinical trial results. The drug is expected to end an eight-year streak of having no first-line antidepressant launched in the world.

The results presented at this year’s APA annual meeting are from a multicenter, randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of LY03005 in treating MDD. A total of 558 MDD patients were enrolled in the study and randomly divided into three dosage groups (160mg of LY03005, 80 mg of LY03005, and placebo) for 8 weeks of treatment. The results of the study demonstrated that LY03005 is effective and safe for MDD patients and can comprehensively improve depressive symptoms. Main findings of the study are as follows:

  • Stable improvement: The MADRS total score, the response rate, and the remission rate were significantly better in the two treatment groups than in the control group

Primary endpoint: After 8 weeks of treatment, the change of the mean Montgomery-Åsberg Depression Rating Scale (MADRS) total score from the baseline of the two treatment groups was better than that of the control group; and the least square mean (LSM) difference of 160mg and 80mg groups versus the control group was -5.06 and -5.46 respectively (P<0.0001 for both), which were statistically significant.

Secondary endpoints: 1) After 8 weeks of treatment, the change of the mean 17-item Hamilton Depression Scale (HAM-D17) total score from the baseline of the two treatment groups was better than that of the control group and was statistically significant (P<0.0001 for both). 2) After 8 weeks of treatment, the MADRS response rate (change of the MADRS total score ≥50% from the baseline) of 160mg and 80mg groups was 73.9% and 79.9% respectively, and the MADRS remission rate (the MADRS total score ≤12) was 52.2% and 51.6% respectively, with all of them being statistically significant.

  • Safe and well-tolerated with no impacts on sexual functioning, bodyweight, or sleep, and not causing somnolence

Safety results: LY03005 was well-tolerated and had a good safety profile with mostly mild to moderate adverse events. There were only a few adverse event-caused treatment discontinuations, and there was no drug-related serious adverse event.

The Arizona Sexual Experience Scale results showed that LY03005 had no statistically significant difference from the placebo in terms of a negative impact on sexual functioning; the mean bodyweight was slightly below the baseline in the two treatment groups, but did not change significantly in the control group; the incidence of somnolence was 1.63% in both treatment groups, which was lower than that caused by other antidepressants; the incidence of insomnia in the two treatment groups was similar to that in the control group.

Help patients get back to normal by improving depressive symptoms in a comprehensive way

MDD is one of the most common mental disorders. It has a high incidence rate and recurrence rate and is severely incapacitating. MDD is a leading cause of disability and a major contributor to the overall disease burden worldwide. Treating MDD aims to control symptoms, increase clinical cure rate, reduce disability and suicide rate, and prevent relapse and recurrence by diagnosing it earlier and administering standard therapies in a timely manner. A clinically successful treatment will eliminate the symptoms, reduce the risk of recurrence, improve the patients’ quality of life, and allow them to achieve social recovery.

Dr. Tian Jingwei, Project Leader of LY03005, Vice President of Non-Clinical Research and Head of New Drug Discovery at Luye Pharma Group, said: " The global prevalence of MDD is around 4.4%, and over 50 million MDD patients are in China. The current available antidepressants have unmet patient needs such as slow onset, ineffectiveness in improving patients' loss of interest, and inducing sexual dysfunction and somnolence. 20%-35% of the patients still have residual symptoms after treatment, which seriously affect their social life and work. LY03005 is developed as a 5-HT/NE/DA triple reuptake inhibitor. With the addition of DA reuptake inhibition, LY03005 becomes safer and more effective in treating MDD. The clinical trial results showed that LY03005 is able to improve patients’ depressive symptoms comprehensively. The good safety profile of the drug makes it easier for patients to receive a standard treatment throughout the course, to help them get back to normal faster."

Outside China, the NDA for LY03005 is also being reviewed in the U.S. and Phase I clinical trials for it have been completed in Japan. The drug is indicated for treating MDD in both cases. In addition, LY03005 has been approved for Phase III clinical trials for the treatment of Generalized Anxiety Disorder in China. More clinical studies will help to unleash the full therapeutic potential of LY03005, which is expected to bring a new treatment option to patients who are suffering from such diseases.

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