China-based Frontier Biotechnologies Inc. (SHA: 688221) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase II/III clinical study assessing its FB2001 atomized inhalant bofutrelvir in mild and common COVID-19 patients. This marks a significant step forward in the development of innovative treatments for COVID-19.
FB2001 Profile
Frontier Bio holds global rights to the clinical development, manufacturing, and commercialization of FB2001, a COVID-19 3CL protease inhibitor co-developed by the Shanghai Institute of Materia Medica and the Wuhan Institute of Virology. Preclinical studies have demonstrated that FB2001 has a good safety profile in rats and dogs when administered by aerosol inhalation. The drug has shown high concentrations in the upper respiratory tract and lungs of rats and dogs, indicating effective delivery to target tissues.
Efficacy and Safety
In vivo efficacy studies have shown that FB2001 has significant antiviral effects through inhalation and intranasal administration. The drug can significantly reduce the viral load in the lungs of mice, highlighting its potential as an effective treatment for COVID-19. The upcoming Phase II/III clinical study will further evaluate the safety and efficacy of FB2001 in COVID-19 patients, aiming to provide robust clinical data to support its development and potential regulatory approval.-Fineline Info & Tech
