Gelonghui May 23 丨 Laikai Pharmaceuticals-B (02105cryptogamesfreetostart. HK) issued an announcementcryptogamesfreetostart, the Group has obtained approval from the U.S. Food and Drug Administration ("FDA ") to conduct a Phase III clinical trial protocol for LAE002 (afuresertib, an AKT inhibitor) in combination with LAE001 (a dual CYP17A1/CYP11B2 inhibitor)(" LAE201 ") in patients with metastatic castration-resistant prostate cancer (mCRPC) after standard of treatment.
The group will be launched in the United States in June 2021 and in South Korea in September 2022cryptogamesfreetostartThe international multicenter Phase II clinical trial of LAE201 in patients with mCRPC after standard treatment was conducted. The trial was an open-label, dose escalation and dose expansion study designed to assess the efficacy and safety of this combination candidate. The study showed positive treatment effects in patients with mCRPC. As of November 21, 2023, at the recommended dose for Phase II, 40 patients have been enrolled at 1