The Chinese Center for Drug Evaluation (CDE) has granted approval to Transcenta for commencing a Phase II clinical trial of anti-sclerostin monoclonal antibody, TST002 (Blosozumab), in individuals with reduced bone mineral density (BMD).

This trial will analyse the tolerability, safety, and pharmacokinetics of the antibody, following single and multiple intravenous doses in the study subjects.

Being evaluated as a drug candidate for osteoporosis and other bone loss conditions, TST002 possesses both anabolic and anti-resorptive properties.

There are no anti-sclerostin antibody therapies currently approved for usage in China.

Transcenta Global Medicine Development executive vice-president and chief medical officer Dr Caroline Germa said: “We are excited to have received the clearance to move forward from CDE. Our Phase II will assess several regimens of TST002 (Blosozumab) with reduced dosing frequency, bringing us closer to our Phase III. 

“We look forward to fully exploring the differentiated profile of TST002 to address the unmet medical need of the large patient population who suffers from osteoporosis.”

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The company had reported unblinded data from a Phase I trial of TST002 (Blosozumab) in May 2023.

Findings demonstrated the overall favourable tolerability and safety of the antibody at all tested dose levels. 

Following a single dose ranging from 200mg-1,200mg, TST002 offered a clinically meaningful rise in lumbar spine BMD on day 85.

The company concluded the enrolment of subjects with first-line CLDN18.2 expressing gastric/gastro-oesophageal junction (G/GEJ) adenocarcinoma in cohorts C and G of its Phase II trial of Osemitamab (TST001) in May.