China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that the market filing for its drug candidate RAY1216, a 3CL protease (3CLpro) inhibitor, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step towards the potential commercialization of the drug for COVID-19 treatment.
Mechanism and Clinical Performance
RAY1216 targets the main protease of the novel coronavirus, inhibiting the cleavage of the virus precursor protein and blocking virus replication to achieve a therapeutic effect. The drug demonstrated good safety, tolerability, and pharmacokinetic profiles in a Phase I clinical study. In dose exploratory studies, RAY1216 combined with ritonavir was shown to rapidly reduce the RNA load of COVID-19 and shorten the time for viral nucleic acid to turn negative.
Phase III Study Results
The randomized, double-blind, placebo-controlled Phase III study enrolled 1,359 mild SARS-CoV-2 patients who took RAY1216 orally for 5 consecutive days. The primary endpoint was the duration of clinical symptom recovery. As of the announcement, the study has reached its pre-set primary efficacy endpoint with a good safety profile, and the adverse events rate was comparable to the placebo group.-Fineline Info & Tech
