China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of enrollment of 1,208 patients in a Phase II/III clinical study for its SIM0417, an oral COVID-19 drug candidate being co-developed with the Chinese Academy of Science’s Shanghai Institute of Materia Medica (SIMM) and the Wuhan Institute of Virology.
Study Design and Objectives
The multi-center, randomized, double-blind, placebo-controlled Phase II/III study, carried out in 43 centers across 20 provinces (municipalities and autonomous regions), is designed to assess the efficacy and safety of the drug in mild to moderate COVID-19 adult patients. Participants will receive SIM0417 orally for 5 consecutive days. The study endpoints include the time required to recover from COVID-19 symptoms, the decrease in viral load, and other relevant metrics.
SIM0417: A Promising Oral COVID-19 Drug
SIM0417 has the potential to become a new generation of oral COVID-19-specific drug, with strong inhibitory effects against a variety of COVID-19 variants, including the Delta strain. The drug demonstrated good antiviral activity and a safety profile in preclinical animal models against the key protease 3CL necessary for the replication of the novel coronavirus. Simcere struck a licensing deal with SIMM in November 2021, obtaining exclusive global development, manufacturing, and commercialization rights to the drug. Clinical trial approvals were awarded in March and May this year in China for assessment against mild to moderate COVID-19 infections and post-exposure prophylactic treatment for people exposed to the virus following a positive test, respectively.-Fineline Info & Tech
