On 17th Dec 2021, Shanghai SIMR Biotechnology Co., Ltd. (here in after referred to as "SIMR" or "Company”) announced that company’s investigational drug SR419, the first asset of SIMR entering the clinical stage, has been granted the approval for a Phase II clinical study by the U.S. FDA . SR419 is developed by the company with innovative mechanism for the treatment of peripheral neuropathic pain and has been approved with China's IND earlier in June 2021.
Dr. Kai Wu, Co-CEO and Head of Clinical Development of SIMR, commented that: “The company has carried out multiple clinical trials for SR419 in Australia and China. The findings to date demonstrate that SR419 is safe and tolerable with the potential in efficacy comparable or even better than pregabalin. The approval reflects the recognition of SR419 and its Phase II study design by FDA, and we will take this opportunity to accelerate the development of SR419 ”.
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 general 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 commonly used treatment for neuropathic pain, the annual global sales of pregabalin (Lyrica) has reached about $4.1 billion in the past 10 years, but its efficacy is not ideal, with nearly 50% of patients not experiencing effective pain relief after treatment. Therefore, there are significant unmet medical needs for this disease.
SIMR is a biotechnology company dedicated to the discovery and development of innovative drugs for pain, inflammation, and central nervous system related diseases. Since its establishment in 2014, the company has established a research and development platform of more than 3,000 square meters, with comprehensive drug discovery and development capabilities.