China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), announced that its randomized, double-blind, placebo-controlled, multi-dose escalation and dose exploration Phase II clinical study for the anti-IL-17A monoclonal antibody (mAb) SSGJ-608 in moderate to severe plaque psoriasis has reached its primary endpoint.
Study Details
The study, which included multi-dose escalation (Part 1) and multi-dose expansion (Part 2), was conducted over 52 weeks. Results showed that at week 12, the proportion of subjects achieving PASI 75, PASI 90, and sPGA 0/1 in each dose group of Part 2 was significantly higher than in the placebo group (all P values < 0.0001). The proportion of subjects achieving PASI 100 was also significantly higher than the placebo group (P value < 0.01). SSGJ-608 began to take effect 2-4 weeks after the first administration, with efficacy continuing throughout the treatment cycle. Overall safety was good, with no new safety signals observed. Dosing and follow-up are ongoing.
Mechanism of Action
SSGJ-608 can selectively bind to human IL-17A, neutralizing its activity and effectively inhibiting the release of inflammatory factors, thereby inhibiting the biological activity of IL-17A.
Market Context
IL-17A products on the global market include Novartis’ Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab), and Biocad’s Efleira (netakimab), which generated a combined USD5.78 billion in global sales in 2020. Other IL-17A-targeted products under development include UCB’s bimekizumab (IL-17A/F), Novartis’ CJM112, Johnson & Johnson’s CNTO6785, Genrix Bio’s GR1501, Qyuns Therapeutics’s QX002N, Junshi Bio’s JS005, and Huahai Pharma’s HB0017.-Fineline Info & Tech
