China-based Frontier Biotechnologies Inc. (SHA: 688221) announced that a registrational clinical filing for its FB2001 atomized inhalant bofutrelvir has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of FB2001 as a potential treatment for COVID-19.
Global Rights and Development
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 Wuhan Institute of Virology. The injectable version of the drug is currently being assessed for its efficacy and safety in a global multi-center, randomized, double-blind, placebo-controlled Phase II/III study in hospitalized COVID-19 patients.
Preclinical Study Results
Preclinical studies have demonstrated that FB2001 has a favorable safety profile in rats and dogs when administered by aerosol inhalation, with high drug concentrations observed in the upper respiratory tract and lungs. In vivo efficacy studies have shown significant antiviral effects through inhalation and intranasal administration, with the drug significantly reducing viral loads in the lungs of mice. Specifically, inhalation of FB2001 can reduce viral load in the lungs by 4.6 log10 copies/ml, equivalent to 99.998% suppression of the virus. Intranasal administration can reduce viral load by 3.6 log10 copies/ml, equivalent to 99.97% suppression.-Fineline Info & Tech
