Luye Pharma Group today announced that the Group’s Class 1 new chemical entity (NCE) product Anshufaxine Hydrochloride Extended-Release Tablets (LY03005) has met the predefined endpoints in a phase III clinical trial in China.
LY03005, a central nervous system (CNS) product developed on Luye Pharma’s new therapeutic entity / new chemical entity technology platform, is a serotonin (5-HT)-norepinephrine (NE)-dopamine (DA) reuptake inhibitor (SNDRIs) for the treatment of Major Depressive Disorder (MDD).
The phase III trial showed that LY03005 is safe and effective in the treatment of MDD and has a triple reuptake inhibitor profile with a comprehensive improvement of depressive symptoms, especially in the relief of anhedonia, improvement in cognitive function, and no impact on sexual function.
Positive Phase III Clinical Trial Results with Statistically Significant Improvement of Symptoms
The phase III trial for LY03005 conducted in China was a multi-center, randomized, double-blind, placebo-controlled study aimed at verifying the efficacy and safety of LY03005 in the treatment of MDD. A total of 558 Chinese adult depressive disorder patients who met the DSM-5 diagnostic criteria were enrolled and randomized into LY03005 80 mg, 160 mg and placebo groups, in a 1:1:1 ratio for an 8-week double-blind treatment study. Statistically significant improvements in both primary and secondary endpoints were observed in the LY03005 groups with once daily oral administration of 80 mg and 160 mg compared with placebo group.
- Primary efficacy endpoint data demonstrated a statistically significant improvement (P < 0.0001) through changes in Montgomery-Asperger Depression Scale (MADRS) total score at the end of week 8 (vs. baseline) in the 80 mg and 160 mg LY03005 groups in comparison with placebo group respectively;
- Secondary efficacy endpoint data showed statistically significant improvements (P<0.0001 or P<0.05) through changes in 17-item Hamilton Depression Scale (HAM-D17), Clinical Global Impression (CGI), Hamilton Anxiety Scale (HAM-A), HAM-D17 Anxiety/Somatization Factor, HAM-D17 Cognitive Impairment Factor, HAM-D17 Blocking Factor, MADRS Anhedonia Factor Score and Sheehan Disability Scale (SDS) total score at the end of week 8 (vs. baseline) in the 80 mg and 160 mg LY03005 groups in comparison with placebo group respectively;
- Safety data showed that LY03005 was safe and well tolerated. Most of the adverse events (AEs) were mild and moderate with rare treatment termination. No related Serious Adverse Events (SAEs) occurred. Common AEs (incidence>5%, more than twice as much as placebo) observed in LY03005 groups included nausea, vomiting, headache, drowsiness, etc. There was no difference between LY03005 and placebo in Arizona Sexual Experience Scale (ASEX) score and no patient developed Treatment Emergent Sexual Dysfunction (TESD) in the study.
Clinical Advantages of SNDRIs Help Alleviate Heavy Disease Burden of MDD
According to the World Health Organization, MDD is one of the most common mental disorders, with approximately 350 million sufferers around the world. The disease has a high rate of incidence and recurrence, and is severely incapacitating. It is the leading cause of incapacity worldwide and a major contributor to the overall global burden of disease. Depression affects 2.1% of the population in China, and based on the huge demand from patients, IQVIA data shows that the market for anti-depressants in China grew to RMB 6.31 billion in 2020.
Traditional anti-depressants such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are typically associated with disadvantages such as anhedonia, sexual dysfunction, and inability to improve cognitive impairment. Compared with traditional anti-depressants, SNDRIs have clear clinical advantages and are expected to be relatively beneficial in helping preserve patients’ sexual function, as well as producing a more rapid onset, and providing better efficacy.
Luye Pharma has obtained patents covering the chemical compound, crystal form and formulation of LY03005. Patents relating to the chemical compound and crystal form have been granted in target markets such as China, the U.S., Europe, Japan and Korea. Luye Pharma plans to register and launch LY03005 in the U.S., Japan, China, Europe and other markets. In addition to China, the drug has entered phase I clinical studies in Japan and is currently in the new drug application stage in the U.S.
Robust CNS Portfolio with Unique Clinical Value
The CNS therapeutic area including MDD is one of the core strategic areas of focus for Luye Pharma. For more than a decade, the company has focused on building its NCE and novel drug delivery technology platforms based on clinical needs. In addition, the development of a product pipeline containing a series of differentiated innovative drugs and formulations has come to fruition, and will continue to bear fruit in the future.
In January of this year, Rykindo® (Risperidone Microspheres for Injection (II)) for the treatment of schizophrenia was granted marketing authorization in China, making it the first innovative microsphere formulation developed independently by a Chinese company. That same month, Rivastigmine Transdermal Patch (Brand Name: 金斯明®) for the treatment of Alzheimer’s disease, made its official appearance on the shelves of hospitals and pharmacies in nearly 50 cities across China.
Luye Pharma currently has multiple new drugs under development, targeting various CNS diseases including Parkinson's disease, Alzheimer's disease, schizophrenia, depression and bipolar disorder. These drugs have entered the late clinical development stages or new drug application stage in China, the US and Europe, as well as other countries and regions.
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