Gelonghui December 3rd | Yifang Biology (688382.SH) announced that the self-developed novel oral selective inhibitor targeting TYK2, D-2570, has recently completed a Phase II clinical trial for psoriasis and has achieved positive clinical trial results.
This trial is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study aimed at evaluating the efficacy and safety of D-2570 in treating moderate to severe plaque psoriasis. According to the protocol, a total of 161 psoriasis patients were recruited for this trial, with participants divided into three different doses of D-2570 and a placebo group. The primary endpoint of the trial was the percentage of subjects achieving at least a 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 12 (PASI75). Preliminary results of this trial showed that all three dose groups met the primary endpoint. Other efficacy endpoints, including PASI90, PASI100 (improvement in PASI score by ≥90% and ≥100% from baseline), and static Physician's Global Assessment (sPGA) 0/1 (complete or almost complete clearance of lesions), all showed significant improvement.
Patients who received low, medium, and high doses of D-2570 orally once daily had a PASI75 response rate of 85.0%-90.0% after 12 weeks, significantly higher than the placebo group (12.5%), reaching the primary endpoint. The PASI90 response rates for the three dose groups were 70.7%-77.5%, compared to 5.0% in the placebo group. The PASI100 response rates were 39.0%-50.0%, versus 2.5% in the placebo group. The sPGA 0/1 response rates were 80.5%-87.5%, while the placebo group was 20.0%. Compared to the placebo group, all efficacy indicators in each group showed statistically significant differences (P<0.001). All dose groups of D-2570 demonstrated good tolerability and safety, with most adverse events and reactions during treatment being mild to moderate. The overall incidence rate was slightly higher than in the placebo group, and no serious adverse events (SAE) were reported. Similar to the safety profile of other TYK2 inhibitors, no new safety signals were observed.
