Out of the total participants, 77 received 200mg of EDP-235. Credit: Önder Örtel on Unsplash.

Enanta Pharmaceuticals has reported positive top-line results from the SARS-Cov-2 PRotease INhibitor Treatment (SPRINT) Phase II clinical trial of EDP-235 for the treatment of mild or moderate Covid-19.

The placebo-controlled, double-blind, randomised study has examined 231 non-hospitalised, symptomatic adults with Covid-19 who were not at high risk for severe disease.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Out of the total participants, 77 received 200mg of EDP-235, 78 received 400mg and the remaining were treated with a placebo.

Evaluation of the safety and tolerability of EDP-235 was measured as the primary endpoint. Symptoms, antiviral activity, and pharmacokinetics were considered as the secondary endpoints of the study.

The study met the primary endpoint while key secondary endpoints evaluating virologic effect were not met.

See Also:

A dose-dependent improvement in total symptom score was observed in EDP-235-treatment group compared to placebo who received the first dose starting as early as day one.

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.

Statistically significant improvement was also observed with EDP-235 at 400mg at all time points in patients enrolled within three days of symptom onset.

Despite the lack of virologic effect as measured in the nose, improvement in the key secondary endpoint of total symptom score was observed in patients treated with EDP-235 against placebo.

Enanta Pharmaceuticals senior vice-president and chief medical officer Scott Rottinghaus said: “The data from our Phase II SPRINT trial demonstrated a favourable safety profile and an improvement in clinical symptoms, suggesting that EDP-235 may have an impact on clinically meaningful endpoints.

“We are continuing to evaluate data from the trial and are focusing on partnership opportunities for Phase III and on the potential for a different Phase II study in acute or long Covid that could further demonstrate the efficacy of EDP-235.”