Transcenta Holding Limited announced the successful dosing of first patient in China Phase I Study of TST002 for the treatment of osteoporosis.
This Phase I clinical trial is a randomized and double-blind, placebo-controlled, single-ascending-dose, multi-center study designed to evaluate the safety, tolerability, and pharmacokinetics profile of TST002 as a treatment in patients with osteoporosis.
TST002 (Blosozumab) is a humanized anti-sclerostin monoclonal antibody as a drug candidate for osteoporosis and other bone loss diseases. It has a dual effect possessing both anabolic and anti-resorptive effects, which stimulates bone formation and inhibits bone absorption, resulting in fast increase in bone mineral density and bone strength. Blocking sclerostin activity in human treated with anti-sclerostin antibody or with naturally occurring genetic deletion has been shown to be an effective approach in increasing bone mineral density (BMD) and reducing bone fracture. Currently there is no approved anti-sclerostin antibody therapy in China yet although Romosozumab from Amgen has been approved in the United States, Europe and Japan.
Transcenta in-licensed Blosozumab (TST002) from Eli Lilly and Company (“Eli Lilly”) for development and commercialization in Greater China in 2019. Eli Lilly has completed phase II clinical studies of Blosozumab in the United States and Japan and obtained promising safety profile and efficacy data. Transcenta successfully completed technology transfer, established manufacturing process in its Hangzhou HJB facility, and completed GMP production for clinical use as well as the additional preclinical studies as required by the CDE for TST002 IND application in China. IND for TST002 China study was cleared from the NMPA on Sept. 22nd, 2021 for testing TST002 directly in patients with osteopenia.
“TST002 can potentially become the second anti-sclerostin monoclonal antibody in the world.” said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta. “We look forward to conducting in-depth study to further evaluate the safety and tolerability of TST002 and bring more efficient and diversified treatment options for Chinese patients with osteoporosis.”
Currently there are over 100 million of people with various degree of osteoporosis in China and over 4 million of them are suffering from osteoporotic fractures. These numbers are increasing due to the influence of lifestyle, diet and aging population, which result in significant health, economic and social burdens associated with osteoporosis related fractures. There are significant unmet needs in this disease area especially in patients with severe osteoporosis despite the availability of a number of agents anti-resorptives such as bisphosphonate and anti-RANKL inhibitor and anabolic agent targeting PTH.
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