Frontier Biotechnologies has reported positive data from the Phase I clinical trial of its drug candidate, FB2001 (Bofutrelvir), in healthy adults to potentially treat acute Covid-19 and long Covid.
The trial enrolled a total of 120 subjects in the US and China.
They were given intravenous doses of FB2001 at either single daily dose ranging from 5mg to 400mg or multiple doses ranging from 30mg to 400mg for five days.
According to the findings, up to 400mg daily dose of FB2001 was found to be safe and well tolerated in trial subjects.
Adverse events of mild-to-moderate severity were observed in the trial without any substantial changes seen between subjects in trial centres in the US and China.
FB2001 showed plasma and lung drug concentrations more than the in vitro antiviral EC50 value, without needing a pharmacokinetic enhancer.
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The trial data builds on preclinical in vivo data, where FB2001 showed to cut down viral loads in the lung and brain tissues of mice.
A small molecule coronavirus main protease (Mpro) inhibitor, FB2001 has demonstrated potent in vitro and in vivo anti-SARS-CoV-2 activity.
Frontier Biotechnologies CEO Dr CJ Wang said: “This promising result will spur us on to strive for success in later-stage trials.
“We believe that the work done at Frontier Biotech can elevate our efforts in the fight against Covid-19 in China and abroad.”
The company has commenced a registrational Phase II/III BRIGHT trial to enrol nearly 1,200 hospitalised Covid-19 patients in clinical centres across the globe.
The trial will analyse the use of FB2001 to lower the time to recovery in these patients.