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.
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.
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.
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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.”