Enanta Pharmaceuticals has reported positive topline findings from a Phase I clinical trial of oral antiviral, EDP-235, in healthy adults to potentially treat Covid-19.
The first-in-human, double-blind, randomised, placebo-controlled trial is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of oral single ascending doses (SAD) and multiple ascending doses (MAD) of EDP-235.
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Both SAD and MAD cohorts of the trial enrolled eight subjects, categorised into a 3:1 ratio to receive EDP-235 or placebo for seven days.
To streamline the selection of EDP-235 dosage, the trial analysed several single and multiple doses in fasted and fed states.
According to the trial results, favourable safety, tolerability and PK were reported.
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Robust exposure multiples over the EC₉₀ were observed in the trial with 200mg and 400mg doses of EDP-235.
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By GlobalDataFurthermore, a dosage of up to 400mg of EDP-235 was generally safe and well-tolerated in healthy participants for up to seven days.
Exposure of EDP-235 rose almost proportionally with increasing single and multiple doses, with a uniform half-life of 13 to 22 hours, offering a PK profile that suits once-a-day dosing.
A rise in exposure was reported with food administration of a standard meal.
These data support the progression of the oral antiviral into a Phase II trial of once-daily dosage without requiring ritonavir.
Following a review by the US Food and Drug Administration, the company plans to begin the Phase II trial of 200mg and 400mg once-daily dose of EDP-235 in the fourth quarter of this year.
A coronavirus 3CL protease inhibitor, EDP-235, can be administered once-a-day treatment for Covid-19.
Enanta Pharmaceuticals president and CEO Jay Luly said: “We are very pleased with the encouraging results from our Phase I study of EDP-235 showing that it was generally safe and well-tolerated up to a once-daily dose of 400mg, which provided plasma drug levels that were six-fold and 12-fold over the plasma protein adjusted EC90 for the Alpha variant and the Delta variant, respectively.
“Moreover, EDP-235 is projected to have four times higher drug levels in lung tissue compared to plasma, which would drive exposure multiples to 24-fold and 48-fold for the respective variants.”
In February this year, the company dosed the first participant in the Phase I trial of EDP-235 for Covid-19.
