On 26th Dec 2022, Shanghai SIMR Biotechnology Co., Ltd. (hereinafter “SIMR”) announced that SR1375, a drug candidate for the treatment of diabetic retinopathy with a new mechanism of action, that is independently developed by the company, has been successfully completed the Phase I bridging clinical trial in China. The First-in-human trial has been successfully completed in Australia previously.
Dr. Kai Wu, Co-CEO and Head of Clinical Development of SIMR, mentioned that: "SR1375 is the company's 2nd drug candidate to enter the clinical stage, and its Phase II clinical trial has been approved by the US FDA previously. This time, We’re very excited about the successful completion of the Phase I bridging clinical trial in China. This is of great significance for the assessing on the possibilities of racial differences for SR1375, reducing repeated trials, and shortening the global approval cycle of new drugs, and it is also an important step to advance the SR1375 into global clinical development."
SR1375 is a First-in-class, small molecule inhibitor, that is independently developed by SIMR. The first indication to be developed is diabetic retinopathy (DR). The patient population with DR worldwide will increase to 191 million by 2030. If no effective therapeutic measures are taken, the vision of these patients will be seriously threatened. Currently, the main treatment for DR is intravitreal injection of anti-vascular endothelial growth factor (Anti-VEGF) drugs. Among them, two intravitreal injections of Anti-VEGF, aflibercept and ranibizumab, had reached a total global annual sale of 12.8 billion USD in 2021. However, about 50% of DR patients receiving Anti-VEGF therapy only achieved a partial response or even no response.
The advantage of SR1375 is that the drug candidate not only has a new mechanism of action, but also can be administered orally, which breaks the limitation of clinical application of Anti-VEGF that must be injected intravitreally. In animal models, SR1375 exhibited comparable efficacy to Anti-VEGF, and it is expected to provide a more convenient, safe, and effective therapeutic option for many DR patients.
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 9 pipelines on progress, 3 assets are on Phase I/II multinational clinical trials, and one got FDA approval of Fast Track Designation.
The company is headquartered in Shanghai, China, and has branches in Guangdong, Jiangsu, Australia, and the United States.