Phase 1 osteoporosis drug trial.
Transcenta has dosed the first subject in the Phase I clinical trial of its drug candidate, TST002 (Blosozumab), to treat osteoporosis in China.
A humanized anti-sclerostin monoclonal antibody, TST002 is being developed for osteoporosis, as well as various other bone loss ailments.
It has dual anabolic and anti-resorptive effects, which elicit the formation of bone and hinders bone absorption, resulting in a rapid increase in mineral density and strength of the bone.
In 2019, the company obtained a license from Eli Lilly and Company for developing and commercializing Blosozumab in Greater China.
Transcenta carried out technology transfer, set up production process in its Hangzhou HJB facility, and concluded GMP production for clinical use and further preclinical studies needed by the Center for Drug Evaluation (CDE) for submitting investigational new drug application (IND) for TST002 in China.
Furthermore, Transcenta received IND clearance from the Chinese National Medical Products Administration (NMPA) last year for carrying out trial of TST002 in osteopenia patients in the country.
The randomized, single-ascending-dose, double-blind, placebo-controlled, multicentre Phase I trial will assess the safety, tolerability and pharmacokinetics of TST002 to treat individuals with osteoporosis.
Transcenta executive vice-president, global R&D head and CMO Dr Michael Shi said: “TST002 can potentially become the second anti-sclerostin monoclonal antibody in the world.”
“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.”
In the Phase II trials of Blosozumab in the US and Japan completed by Eli Lilly, the antibody demonstrated a favorable safety profile.