Ascletis Pharma has reported positive topline data from the Phase I multiple ascending dose (MAD) clinical trial of its prodrug, ASC10, in healthy participants to potentially treat Covid-19.

According to the trial findings, all doses of ASC10, including an 800mg twice a day dose, were found to be safe and well tolerated in subjects in China. 

The safety profiles of ASC10 and a placebo were also reported to be similar. 

The active drug ASC10-A’s exposure following twice-a-day dosing with 800mg of double prodrug ASC10 in Chinese participants was 94% of that following twice-a-day dosing with 800mg of single prodrug molnupiravir in Japanese participants. 

In Chinese participants, on administering an 800mg dose, the plasma concentrations of the double prodrug ASC10 were found to be less than the detection limit.

Food had no impact on the exposure of ASC10-A, signifying that ASC10 could be administered with or without food.

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.

Following the data from the Phase I trial of ASC10 and molnupiravir’s clinical efficacy findings in American, Japanese, and Chinese subjects, a twice a day 800mg dose of ASC10 was chosen for a registrational trial.

The oral tablet formulation of the ASC10 prodrug needed for the trial was developed using Ascletis’ technology.

The active drug ASC10-A is said to have potent antiviral activity against several Omicron variants such as BA.5 and BA.2.75. 

At present, the single prodrug, molnupiravir, is approved or authorised for usage in several regions including the US and Japan. 

Ascletis founder, chairman and CEO Dr Jinzi Wu said: “The Phase I clinical data have confirmed the druggability of ASC10 for Covid-19. 

“With the global patent filings, we expect that ASC10 will make contributions to fighting against the Covid-19 pandemic inside and outside China.”

The latest development comes after the China National Medical Products Administration (NMPA) granted clearance for the company’s Investigational New Drug (IND) application for the Phase I trial of ASC11 for Covid-19.