China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced the completion of subject enrollment and clinical observation for the Phase I clinical study of RAY1216, an innovative oral therapy for the novel coronavirus developed by its subsidiary Guangdong Raynovent Biotech Co., Ltd. The study results demonstrated good safety and pharmacokinetic properties, achieving the expected study objectives.
Drug Details
RAY1216 is a 3CL protease (3CLpro) inhibitor that acts on the main protease of the novel coronavirus. It inhibits the cleavage of the virus precursor protein, thereby blocking virus replication to achieve a therapeutic effect. Preclinical studies have shown that RAY1216 has a significant inhibitory effect on the 2019-nCoV 3CL protease, with high in vitro inhibitory activity against different 2019-nCoV variant strains. In the K18-hACE2 mouse model infected with the 2019-nCoV delta strain, RAY1216 effectively protected the mice, significantly reducing the virus titer in lung tissue, improving lung lesions, and significantly alleviating tissue damage caused by the novel coronavirus. Anti-coronavirus activity studies in vitro and in vivo have shown that the anti-coronavirus effect of RAY1216 is comparable to that of PF-07321332.
Clinical Study Design
The Phase I study was a randomized, double-blind, placebo-controlled, single/multiple dosing, dosage escalation trial. It was designed to assess the safety, tolerability, pharmacokinetic profile, and the effect of food on pharmacokinetics of RAY1216. A total of 88 healthy adult subjects were enrolled in the study.-Fineline Info & Tech
