Transcenta has reported positive results from a Phase I trial of TST002 (Blosozumab) in Chinese postmenopausal women and elder men with reduced bone mineral density (BMD).
The trial evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of a single TST002 dose in these patients.
The randomised, double-blind, placebo-controlled, dose-escalation trial assessed a single intravenous injection of TST002 either at 200mg, 400mg, 800mg or 1,200mg doses or a matching placebo.
A total of 32 patients were included and treated as part of the trial.
Preliminary evaluation of the unblinded data demonstrated that the overall safety and tolerability of TST002 in all dose cohorts was encouraging.
When compared with earlier clinical trials of Blosozumab in European, American and Japanese patients, no new safety signals were observed during the trial.
No dose-limiting toxicity, serious adverse event (SAE), or aftereffects (AE) led to dose alteration or death were reported.
All the adverse events were found to be transient.
In terms of efficacy, all dose cohorts from 200mg to 1,200mg have demonstrated a clinically significant increase in lumbar spine BMD on day 85 following a single TST002 dose and in comparison with those of Blosozumab single dose study at similar levels.
On average, the increase of lumbar spine BMD at day 85 from baseline was from 3.52% to 5.94% across dose cohorts, with the increase of lumbar spine BMD in the placebo group being only 0.3%.
These data showed that TST002 is capable of treating osteoporosis, thereby supporting Transcenta’s plan to commence Phase II trials with various doses once every two to three months.
In 2019, Transcenta in-licensed the Great China rights of Blosozumab from Eli Lilly and Company to develop and commercialise in Greater China.
Transcenta global medicine development executive vice-president and chief medical officer Dr Caroline Germa said: “We have observed encouraging preliminary BMD data with TST002 (Blosozumab) and the data generated support further exploration of our compound in Phase II.”