Shanghai, China, July 26, 2019 ---- Shanghai SIMR Biotechnology Co., Ltd. (hereinafter referred to as "SIMR" or "Company") initiated the first-in-human study of candidate drug SR419 in Australia. SR419 is a first-in-class drug candidate for peripheral neuropathic pain, and it was discovered and developed by SIMR. The first subject has been enrolled and dosed at the Linear Clinical Research Center. The main objectives of this clinical study are to evaluate the safety, tolerability, and pharmacokinetic profiles of SR419 in healthy subjects.

SIMR is a biopharmaceutical company focusing on developing innovative drugs for nervous system diseases. “As the company's first candidate drug entering the clinical phase, initiation of the first-in-human study of SR419 in Australia is one of the most important milestones in the company's discovery and development of innovative drugs for nervous system diseases.” Dr. Shuai Li, SIMR Founder, Chairman and Chief Executive Officer, is confident and looking forward to the future evaluation of clinical efficacy of SR419. “With the successful dosing of the first subject, SIMR has officially become a clinical stage biopharmaceutical company. With our unique discovery capability, SIMR aims to bring safer and more effective treatments for the patients in China and around the world.”

Dr. Kai Wu, Vice President of Clinical Development of SIMR, said: "The successful dosing of the first subject with SR419 officially marked the start of clinical development for neuropathic pain drugs by SIMR. As a novel non-opioid receptor candidate drug for peripheral neuropathic pain, the preclinical data of SR419 showed the promising efficacy and no CNS side effects, and it has the potential to become the first-in-class for its specific target.” 

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 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 and other nervous system diseases. Since its establishment in 2014, it has built up the capability in discovery (cell biology, pharmaceutical chemistry, process research, formulation research, quality research, pharmacological efficacy evaluation) and clinical development. From 2016 to 2018, SIMR completed the financing of tens of millions RMB at pre-A round and over 100 million RMB at A round.

For more information on SIMR, please visit http://www.simrbio.com.