Luye Pharma Reports First Results from Phase II Clinical Trial of New Ansofaxin Hydrochloride Extended-Release Antidepressant Tablets

CHONGQING, China, 23 December 2021 / PRNewswire / – Luye Pharma Group today released encouraging first results from a Phase II clinical trial of its new antidepressant, Ansofaxine Hydrochloride Extended-Release Tablets (LY03005), at 19e Chinese Medical Association National Psychiatry Conference.

In general, LY03005 demonstrated overall antidepressant efficacy as well as a good safety and tolerability profile based on the initial results of the phase II clinical trial. In particular, no significant adverse events related to sexual function or weight change were found, and no significant increase in drowsiness 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 Request (NDA) phase in China.

The first results published this time come from a multicenter, randomized, double-blind, placebo-controlled phase II study designed to preliminarily assess the efficacy and safety of LY03005 in the treatment of major depressive disorder (MDD). ) and explore the optimal dosage. 260 MDD patients were entered into the study and randomized to receive treatment with LY03005 (at doses of 40 mg, 80 mg, 120 mg and 160 mg) or placebo for 6 weeks. The main findings are as follows:

  • LY03005 met the primary endpoint, showing a good response and remission rate.

The results for the primary endpoint show that the change in the total score of the 17-item Hamilton Depression Rating Scale (HAM-D17) from baseline showed a statistically significant difference (P

For secondary endpoints, LY03005 was superior to placebo for all dosing groups in terms of both change in total score on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to baseline and change in CGI-I score after 6-week treatment, showing a difference in statistical significance (P

  • LY03005 has shown potential for improvement in symptoms such as anxiety and cognitive impairment

For secondary endpoints, LY03005 was superior to placebo for the 40 mg, 80 mg and 160 mg dose groups in terms of HAM-A Total Score, HAM-A Somatic Anxiety Factor Score, and HAM-D17 Anxiety / Somatization factor score, showing a statistically significant difference (P

  • LY03005 showed a good safety and tolerability profile with no significant adverse effects on sexual function, weight or sleep

Safety data show: 1) LY03005 demonstrated a good safety profile and tolerability, and most adverse events were mild or moderate with short duration, rarely leading to discontinuation of treatment; 2) there was no significant difference between LY03005 and placebo in terms of Arizona Sexual Experiences Scale (ASEX) score, and no sexual dysfunction as an adverse event was found in the study; 3) only three cases of weight change were determined to be related or possibly related to the drug used in the study, and all three cases were mild or moderate, showing recovery at the end of treatment; 4) LY03005 was similar to placebo in terms of the incidence of drowsiness.

Full recovery of patients is only possible when the drug used to treat them is safe and tolerable with overall antidepressant efficacy

“The clinical performance demonstrated by LY03005 shows that it helps improve depressive symptoms and functional impairments of patients, leading to full recovery,” said Professor Zhang Hongyan from Peking University Sixth Hospital, who was the principal investigator in the phase II clinical trial. of LY03005. “The drug’s good safety profile makes it easier for patients to receive standard therapy throughout therapy, helping them return to normal more quickly.”

The main clinical manifestations of depression include basic symptoms such as depressed mood and lack of energy as well as concomitant symptoms such as cognitive and sexual disturbances. Many patients would see improvements in their main symptoms after receiving treatment with antidepressants, but their remaining concomitant symptoms may still impair their social functioning or even lead to a relapse into depression. “The treatment of depression should try to completely eliminate all symptoms, including affective, somatic and cognitive symptoms, and aim at improving the quality of life of patients and restoring their social functioning, in order to achieve a stable and full recovery in its true sense, ”added Professor Zhang.

In addition, poor patient compliance is another important factor affecting the prognosis for depression. The safety and tolerability of a drug has a significant impact on the willingness of patients to receive treatment with the drug. A number of patients discontinued treatment due to intolerance, and some of them even refused to receive treatment early on, with results significantly compromised. Treating common side effects of a drug, such as sexual dysfunction, weight gain, cognitive impairment, sedation, or fatigue, is key to increasing treatment adherence.1.

“Developed as a 5-HT / NE / DA TRI, LY03005 is designed to address unmet patient needs, including impaired social functioning and drug intolerance with long-term use,” said Dr Tian Jingwei, Vice President of Non-Clinical Research at Luye Pharma Group, who is also responsible for the LY03005 project team. “Based on various completed studies, we have validated many clinical benefits of the drug for patients. In the future, we will conduct more clinical trials to further unleash its therapeutic potential and help depressed patients return to normal as soon as possible. as possible.”

In addition to China, LY03005 is also in the NDA phase in the United States and has completed Phase I clinical trials in Japan.

Abut Ansofaxin Hydrochloride Extended Release Tablets (LY03005)

LY03005 is a new Class 1 chemical drug in China developed by Luye Pharma Group on its New Therapeutic Entity (NTE) / New Chemical Entity (NCE) platform for the treatment of Major Depressive Disorder (MDD). In vitro and ex vivo studies as well as in vivo brain microdialysis have validated that LY03005 is a serotonin-norepinephrine-dopamine reuptake inhibitor (SNDRI / TRI).

LY03005 inhibits the reuptake of serotonin (5-HT), norepinephrine (NE) and dopamine (DA) by binding to the serotonin transporter (SERT), norepinephrine transporter (NET) and dopamine transporter (DAT). After oral administration, the drug and its metabolite O-Desmethylvenlafaxine (ODV) will be selectively distributed in the hypothalamus with a similar concentration, to exhibit the activity of an SNDRI. A study of the mechanism of action of LY03005 has been published in the global academic journal Frontiers in pharmacology.

About the Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacture and sale of innovative drugs. The company has established R&D centers in China, the United States and Europe, with a strong pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. With a number of new drugs and formulations in the central nervous system and oncology therapeutics areas under investigation in the United States Europe and Japan, Luye Pharma has achieved high-level international standards in new drug delivery technologies, including microspheres, liposomes and transdermal drug delivery systems, and actively carries out strategic developments in the areas of biological antibodies, cell therapies and gene therapies, among others.

Luye Pharma is developing a global supply chain of 8 manufacturing sites with more than 30 production lines in total, establishing GMP quality management and international standard control systems. With over 30 products covering central nervous system, oncology, cardiovascular disease, metabolism, and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets – China, United States, Europe and Japan, as well as in rapidly growing emerging markets.

Reference:

1. Li L, Ma X et al. The Guideline for the Prevention and Treatment of Depression in China. 2. Beijing: Chinese medical multimedia press; 2015. 106-107

SOURCE Luye Pharma Group

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