China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the initiation of a randomized, double-blind, placebo-controlled Phase III study with ethics approval for its RAY1216 in mild and common SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild and common COVID-19 infection, using placebo 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.
RAY1216 Profile
RAY1216 inhibits 3CL protease and the replication of COVID-19, demonstrating a clear mechanism of action. The drug showed a good safety, tolerance, and pharmacokinetics profile in the completed Phase I clinical study. The dose exploratory study indicated that compared to the placebo group and RAY1216 alone, RAY1216 combined with ritonavir could rapidly reduce the RNA load of COVID-19, shorten the time required for viral nucleic acid to turn negative, and maintain a good safety and tolerability profile.
Future Development
The initiation of the Phase III study marks a significant step forward in the development of RAY1216. Guangdong Zhongsheng Pharmaceutical aims to further validate the drug’s efficacy and safety in treating mild and common COVID-19 infections, potentially offering a new therapeutic option for patients.-Fineline Info & Tech
