China NMPA Approved the IND Application for New Glutamate Modulator Troriluzole, Signalling Fresh Hope for OCD Patients
SHANGHAI, Aug. 6, 2021 /PRNewswire/ -- BioShin Limited announced today that China's National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for Troriluzole (BHV4157), BioShin 's new glutamate modulator. The approval allows to initiate the clinical development of Troriluzole Obsessive Compulsive Disorder (OCD) program in China, which include a International Multi-Center Phase III Clinical Trial (BHV4157-303) in patients with OCD and a Pharmacokinetic Trial (BHV4157-110) in Chinese healthy subjects.
OCD is an anxiety disorder characterized by recurrent, unwanted thoughts or repetitive behaviors, often interfering with all aspects of the patients' life. Lifetime prevalence rates of OCD range from 0.8% to 3% worldwide. OCD is a common disease in China, which is more likely to be found among women, with an average age of onset from 19 to 35 years old. More than 80% of OCD patients concurrently suffer from at least one other mental disorder.
Troriluzole is a new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. Troriluzole increases glutamate uptake from the synapse, by augmenting the expression and function of excitatory amino acid transporters located on glial cells that play a key role in clearing glutamate from the synapse, in order to reducing synaptic levels of glutamate.
"Currently, drugs are still the main method of treatment for OCD," said Dr. Karl Lintel, CEO of BioShin. "However, the effective rate of drug treatment and behavioral therapy for OCD is only between 40-50%. This means it is imperative to find new ways to alleviate patients' mental burden and satisfy their other unmet medical needs. As a leading biopharmaceutical company in the industry, BioShin is committed to the discovery, development and marketing of world leading novel life-improving treatments for patients with neurological diseases in China and Asia-Pacific countries. The accelerated acceptance of the IND filing for Troriluzole in China marks an encouraging start, as Troriluzole's research and development in China enters a critical stage. I believe that in the near future, we will be able to introduce safer and more effective treatments to Chinese patients with OCD, providing them with new therapeutic oppoartunities."
Based in Shanghai, BioShin Limited is a biopharmaceutical company focused on the discovery, development and commercialization of novel, life-improving treatments for patients with neuro-immune diseases in China and the Asia-Pacific region. BioShin has a proven and established, late-stage portfolio from its strategic partner, U.S.-based Biohaven Pharmaceuticals Inc., and is poised to quickly launch novel medicines for patients in need. Beyond its current research and development portfolio, BioShin's strategic vision also includes partnering with biopharmaceutical companies, inside and outside China, that seek to discover, develop, and commercialize assets in the region. By bringing together promising assets and a diverse management team with international expertise, BioShin is growing a nimble organization with an entrepreneurial spirit to serve patients throughout the region. For more information, please visit www.bioshin.com.
 Guide to the Prevention and Treatment of Obsessive-Compulsive Disorder in China. 2016 (Edited Edition). Chin J Psychiatry. 2016;49(6):353-66