SINOMAB BIO-B(03681): Positive topline results of Phase 1B clinical trial for SM17 in the treatment of severe specific dermatitis in China.

SINOMAB BIO-B (03681) announced that the positive top-line results of the Phase 1B clinical trial of SM17 in treating specific dermatitis in China, particularly in demonstrating differentiated efficacy in anti-itch effects. This Phase 1B clinical study is a randomized, double-blind, multicenter, placebo-controlled trial aimed at investigating the safety, tolerability, pharmacokinetic characteristics of SM17 and preliminary validation of its effectiveness in patients with moderate to severe Atopic Dermatitis (AD). The Phase 1B study included a total of 32 patients with moderate to severe AD, who were randomly assigned in a ratio of 3:3:2 to receive high dose SM17 (600mg), low dose SM17 (200mg), or placebo treatment. The trial period included a 12-week treatment period followed by a 4-week cessation/maintenance/safety follow-up period. The main endpoint of this trial is the safety profile of SM17, with evaluation of tolerability over the 16-week period, incidence of treatment-emergent adverse events (TEAEs), vital signs, and changes in laboratory parameters.