SINO BIOPHARM (01177) announced that the group's self-developed National Class 1 innovative drug TQH3906, a "TYK2/JAK1 JH2 allosteric inhibitor," has recently completed its Phase II clinical trial for moderate-to-severe plaque psoriasis (PsO). The study results indicate that TQH3906 demonstrated favorable safety and tolerability across all dose groups and met the primary endpoint of the Phase II study. This research was a randomized, double-blind, placebo-controlled, multicenter Phase II study (NCT06542614) designed to evaluate the efficacy and safety of TQH3906 in subjects with moderate-to-severe plaque psoriasis. The study ultimately enrolled 209 patients, including a placebo group and five different TQH3906 dose groups, administered orally once daily.
In terms of efficacy, TQH3906 exhibited a favorable dose-response relationship and identified a plateau in drug effect for the primary endpoint. At the anticipated recommended Phase II dose (RP2D), after 12 weeks of treatment, the PASI 75 (Psoriasis Area and Severity Index improvement ≥75% from baseline) response rate exceeded 90%, and the PASI 90 (improvement ≥90%) response rate surpassed 70%, significantly outperforming the placebo group's PASI 75 and PASI 90 response rates (approximately 10% and 5%, respectively). Its efficacy level is comparable to IL-17/IL-23 targeted biologics and shows superior efficacy compared to other marketed oral psoriasis treatments, such as deucravacitinib and apremilast.
Detailed data from this study will be presented at subsequent international academic conferences. Regarding safety, TQH3906 demonstrated an overall favorable safety profile, with a total incidence of adverse events comparable to the placebo group, and the vast majority of treatment-emergent adverse events (TEAEs) were of Grade 1-2 severity. Its safety characteristics are similar to those of other TYK2 inhibitors, with no new safety signals identified. Compared to antibody-based biologics, oral small-molecule targeted drugs offer advantages such as convenient administration, high tolerability, and good patient compliance.
Currently, the only oral small-molecule drugs approved in China for plaque psoriasis are PDE-4 inhibitors (apremilast, momelotinib) and deucravacitinib (a TYK2 JH2 allosteric inhibitor). However, existing research data indicate that these drugs achieve a PASI 75 response rate of only about 60% and a PASI 90 response rate of only about 40% at 16 weeks of treatment, showing a significant efficacy gap compared to biologics; there is a strong clinical need for oral small-molecule drugs with superior efficacy and controllable safety.
Furthermore, by targeting the pseudokinase domain (JH2) of TYK2/JAK1, TQH3906 significantly enhances its selectivity against JAK2, JAK3, and other kinases. Compared to traditional JAK inhibitors that act on the kinase domain (JH1), TQH3906 possesses higher selectivity and potentially superior safety. Beyond plaque psoriasis, the group will continue to explore TQH3906 for multiple new indications in the fields of autoimmune and dermatological diseases, including inflammatory bowel disease and psoriatic arthritis.
Comments