Rapt Therapeutics, Jeyou announce data from Phase 2 trial of RPT904

RAPT Therapeutics (RAPT) and Shanghai Jeyou Pharmaceutical, formerly called Shanghai Jemincare Pharmaceutical, announced positive topline data from Jeyou’s Phase 2 trial of RPT904 as monotherapy in chronic spontaneous urticaria, CSU. The trial, which was conducted in China, was designed to evaluate the safety and efficacy of RPT904 at dosing intervals of 8 weeks, Q8W, and 12 weeks, Q12W, compared to omalizumab dosed every 4 weeks, Q4W. The study was not a formal non-inferiority study and no statistical hypothesis was tested. The results from this study indicate that RPT904 dosed Q8W or Q12W has comparable efficacy and safety to omalizumab dosed Q4W, and the companies believe these results warrant advancing RPT904 to Phase 3 development. The primary endpoint was change from baseline in the seven-day urticaria activity score at Weeks 8, 12 and 16, and a key secondary endpoint was the proportion of patients with UAS70 at Weeks 8, 12 and 16. After the initial 16-week treatment period, patients were followed for an additional 16 weeks without additional treatment.