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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.