FB2001 (Bofutrelvir) Phase II/III Clinical Trial Protocol Approved by NMPA

Frontier Biotech (stock code: 688221.SH) announced that the Phase II/III clinical study protocol of FB2001 (generic name: Bofutrelvir) is approved by the Center for Drug Evaluation, NMPA. The study is a worldwide multi-center, randomized, double-blind and placebo-controlled Phase II/III trial to evaluate the safety and efficacy of Bufutrelvir for hospitalized Covid-19 patients. Frontier Biotech has signed on with a leading global clinical CRO to conduct this pivotal trial and the study is soon to be initiated.

Bofutrelvir is a SARS-CoV-2 3CL protease inhibitor under clinical development for hospitalized patients as well as for post-exposure prophylaxis of Covid-19. It is a peptidomimetic compound targeting 3CL-protease based on three-dimensional crystal structure of the protease. Preclinical data has shown it has potent activities in vitro and in vivo against SARS-CoV-2 variants such as Alpha, Beta, Delta, and Omicron. Clinical data from two phase 1 trials conducted in the US and China has shown that Bofutrelvir is safe and tolerable with a PK profile (without using a booster like ritonavir) supporting further clinical development.