Transcenta Holding Limited Receives Approval from China Center for Drug Evaluation to Initiate Phase II Clinical Trial of TST002(Blosozumab)
In May 2023, Transcenta presented Phase I unblinded data, which showed that the overall safety and tolerability of TST002 (Blosozumab) in all dose cohorts is favorable. On the efficacy side, all dose cohorts from 200-1,200 mg have shown a clinically meaningful increase in lumbar spine BMD on D85 after a single dose of TST002 (Blosozumab) and comparable to those of Blosozumab single dose study at the similar dose levels. The average increase of lumbar spine BMD at D85 from baseline ranged from 3.52% to 6.20% across dose cohorts, all exceeding the least significant difference (2.77%). The increase of lumbar spine BMD in the placebo group was only 0.30% even with optimal calcium and vitamin D supplemental treatment. In addition, encouraging BMD increase in total hip from 1.30% to 2.24% across dose cohorts were observed after single dose of TST002 (Blosozumab). In comparison, the mean percent change in lumbar spine BMD from baseline to month 12 was 5.4% after one year of Denosumab treatment.