China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the enrollment of the first subject in a randomized, double-blind, placebo-controlled Phase III study for its drug candidate RAY1216, which is being evaluated as a treatment for mild SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild COVID-19, with a placebo serving as the control. Participants will take RAY1216 orally for five consecutive days. The primary endpoint of the study is the duration of clinical symptom recovery.
Mechanism and Clinical Profile of RAY1216
RAY1216 inhibits 3CL protease and the replication of COVID-19, demonstrating a clear mechanism of action. In a completed Phase I clinical study, RAY1216 showed good safety, tolerability, and pharmacokinetic profiles. The dose-exploratory study indicated that, compared to the placebo group and RAY1216 alone, the combination of RAY1216 with ritonavir could rapidly reduce the RNA load of COVID-19 and shorten the time required for viral nucleic acid to turn negative.-Fineline Info & Tech