On October 15, 2021, Shanghai SIMR Biotechnology Co., Ltd. (hereinafter “SIMR” or “Company”) announced that the single dose escalation study for SR419 has been successfully completed. This Phase I bridging clinical trial in China was launched in August 2021 and excellent results were delivered. All dose groups are safe and well tolerated with no serious adverse events. Another SR419 clinical trial in patient population is ongoing in Australia to evaluate preliminary efficacy and safety, which is expected to complete enrollment in the near future.
About SR419
SR419 is a candidate drug for the treatment of peripheral neuropathic pain with a "First -in-Class" mechanism independently developed by SIMR Biotech. Pre-clinical studies have shown that SR419 has better efficacy than pregabalin, and has fewer side effects than pregabalin. Therefore, SR419 has the potential advantages of stronger analgesic effect and less central side effects.
About peripheral neuropathic pain
Peripheral neuropathic pain is the pain caused by damage or pathological changes of peripheral nerves, including post-herpetic neuralgia, diabetic peripheral neuropathy, chemotherapy-induced peripheral neuropathy, and postoperative peripheral neuropathy. Epidemiological data show that the incidence of neuropathic pain in the overall population is about 8%. Diabetic peripheral neuropathy affects about 50% of diabetic patients, and chemotherapy-induced peripheral neuropathy affects nearly 60% of cancer patients after chemotherapy. As the standard treatment for neuropathic pain, the annual global sales of pregabalin (Lyrica) has reached about 5 billion US dollars in the past 5 years, but its efficacy is not ideal, with nearly 50% of patients not experiencing effective pain relief after treatment. Therefore, there is a huge unmet medical need in this disease.
About SIMR
SIMR is an innovation-oriented biopharmaceutical company dedicated to the discovery and development of new drugs for pain, inflammation, and central nervous system-related diseases. The company has a differentiated strategy to do translations, using patient data and animal models to create a standardized and comprehensive system to target discovery and precise clinical design. Since its establishment in 2014, the company has developed its R&D platforms, with a facility of more than 3,000 square meters and comprehensive drug development capabilities such as compound screening, CMC research, preclinical evaluation, and clinical development. There are diversified pipelines comprising clinical stage investigational therapies and preclinical assets to with huge potential on epilepsy, major depressive disorder and Alzheimer’s disease. Headquartered in Shanghai, China, and has branches in Guangdong, Jiangsu, Australia, and the United States.
