China-based Kexing Pharmaceutical (SHA: 688136) has announced receiving ethical approval to conduct a Phase II clinical study for its SHEN26, an oral small-molecule COVID-19 drug co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd. The study aims to assess the efficacy and safety of SHEN26 in mild and common COVID-19 cases.
Study Design and Objectives
The randomized, double-blind, placebo-controlled Phase II study will evaluate the efficacy and safety of SHEN26 in patients with mild and common COVID-19. The primary endpoint will be the change in RNA level (RT-PCR test) of COVID-19 (SARS-CoV-2) from baseline. Kexing Pharma has also filed for pre-IND status in the United States based on existing results, positioning the drug for further global development.
Drug Profile and Preclinical Data
SHEN26 is a novel coronavirus polymerase (RdRp) inhibitor that exerts an antiviral effect by inhibiting viral nucleic acid synthesis. Preclinical data showed that SHEN26 had stronger inhibitory activity against Omicron variants compared with remdesivir. An in vivo efficacy study demonstrated that 50 mg/kg of SHEN26 was equivalent to 200 mg/kg of molnupiravir against COVID-19. In terms of safety, SHEN26 presented a low risk of off-target side effects, with negative results for teratogenicity and mutagenicity, indicating a high treatment index and good safety profile.-Fineline Info & Tech
