China-based biotech Transcenta Holdings Ltd (HKG: 6628) has announced encouraging Phase I clinical study results for TST002, a drug designed to address decreased bone density in Chinese patients.
Phase I Study Design and Findings
The randomized, double-blind, placebo-controlled, dosage escalation Phase I study assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of TST002 in postmenopausal women and elderly men with reduced bone density in China. The study enrolled 32 patients, and preliminary analysis results indicated that TST002 demonstrated good overall safety and tolerability across all dose groups, with no new safety signals identified. On the 85th day following a single dose of TST002 treatment, the lumbar spine bone density in all dose groups increased by an average of 3.52% to 5.94% from baseline, surpassing the minimum significant difference of 2.77%. In contrast, the lumbar spine bone density of the placebo group only increased by 0.3%. These results support the initiation of a multi-dose Phase II clinical study for TST002.
Dual Mechanism of Action and Market Potential
TST002 possesses a dual mechanism of action that generates both anabolic and anti-resorptive effects, stimulating bone formation while inhibiting bone absorption, leading to a rapid increase in bone density and strength. Transcenta aims to follow in the footsteps of Amgen’s anti-sclerostin mAb Evenity (romosozumab), which has been approved in the US, Europe, and Japan and is under clinical development in China. Transcenta in-licensed the drug from Eli Lilly in 2019 for development and commercialization in Greater China, building on the successful completion of Phase II studies in postmenopausal women in the US and Japan.-Fineline Info & Tech
