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  • Milestone - SR1375'S Phase II Clinical Trial Approved by the US FDA

    发布时间:2021年11月01日  


    Shanghai, China, Nov 1,2021 ---- Shanghai SIMR Biotechnology Co., Ltd. (here in after referred to as "SIMR" or "Company") initiated the first-in-human study of candidate drug SR750, indicated for peripheral neuropathic pain. The first subject has been enrolled and dosed in Australia on October 29. The study is a randomized, double-blind, placebo-controlled, escalating single dose study to evaluate the safety, tolerability, pharmacokinetic of SR750 in healthy subjects. In addition, IND application in China and the US for SR750 are also in preparation, and clinical trials in China and the United States expected to be initiated in 2022.

    Dr. Kai Wu, Co-CEO and Head of Clinical Development of SIMR, commented: “SR750 is our third candidate drug entering into clinical stage, and is our second compound for neuropathic pain, representing another breakthrough in analgesia field for the company. We are looking forwards to the clinical data of SR750 in near future. "

    About SR750

    SR750 is a candidate drug with novel mechanism of action for the treatment of peripheral neuropathic pain, which is discovered and developed by SIMR. The results of preclinical studies show that SR750 has excellent safety and pharmacokinetic properties. In addition, SR750 demonstrates the potential of better analgesic efficacy and fewer side effects than pregabalin, a commonly used first-line treatment for neuropathic pain.

    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.

    About SIMR

    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.