Luye Pharma Group announced today that the enrollment and follow-up of patients in a phase III clinical trial, an efficacy and safety comparative study of LY03005 with placebo, has been completed in relation to the company’s product candidate, Ansofaxine Hydrochloride Extended Release Tablets (LY03005), a New Chemical Entity (NCE) and China Class 1 New Chemical Drug. The clinical trial study involved the enrolment of 558 patients, all of whom have completed the study following observations in changes of the ten-item Montgomery-Åsberg depression rating scales (MADRS) total score from baseline as the primary endpoint under blind state.
Indicated for depression, LY03005 is an exclusive CNS product developed under Luye Pharma’s New Chemical and Therapeutic Entities (NCE/NTE) R&D platform. It is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI), with one of the active metabolites being a serotonin-norepinephrine reuptake inhibitor (SNRI).
According to the World Health Organization, depression is one of the most common mental disorders, with approximately 350 million sufferers around the world. The disease has high incidence and high recurrence, and is severely incapacitating. It is the leading cause of incapacity worldwide and a major contributor to the overall global burden of disease. The prevalence of depression in China has reached 2.1%, and based on the huge demand from patients, the IQVIA data shows that the market for antidepressants in China reached 6.27 billion yuan in 2019.
Patients using 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, SNDRI is expected to be relatively beneficial in helping preserve patients’ sexual function, as well as maintaining a better safety profile, producing a more rapid effect, 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.
"Depression seriously affects the physical and mental health of patients, and imposes a heavy burden on their families and on society as a whole,” said a senior management representative from Luye Pharma Group. “We believe that LY03005 will provide patients with new treatment options and increased clinical benefits. We are expediting the development and launch of this drug as quickly as we can.”
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