Enanta Pharmaceuticals has commenced the Phase II SPRINT clinical trial of EDP-235 to treat mild or moderate Covid-19 in non-hospitalised, symptomatic adult patients.
The placebo-controlled, randomised, double-blind trial will assess the safety, tolerability, and antiviral activity of once-a-day 200mg and 400mg oral doses of EDP-235 versus a placebo.
It will enrol nearly 200 patients who are not at high severe disease development risk and will be given EDP-235 or a placebo for five days.
Assessing the safety and tolerability is the primary objective of the trial.
Analysing the virologic endpoints, clinical symptoms and outcomes, and pharmacokinetics are included as secondary objectives.
The company anticipates reporting trial findings in the first half of next year.
A lead 3CL protease inhibitor of the company, EDP-235 showed to hinder the SARS-CoV-2 virus’ replication in multiple cellular models in preclinical research.
In August this year, the company reported positive topline data from a Phase I trial of EDP-235 in healthy adults for the potential treatment of Covid-19.
EDP-235 showed encouraging safety, tolerability, and pharmacokinetics, with robust exposure multiples over the EC₉₀, backing the oral therapy’s potential as a once-a-day antiviral treatment without needing ritonavir.
Enanta Pharmaceuticals president and CEO Jay Luly said: “The initiation of SPRINT is an important milestone in advancing the clinical development of EDP-235 as a once-daily antiviral treatment for Covid-19.
“Our recent encouraging Phase I data for EDP-235 demonstrated that 200mg and 400mg once-daily doses were safe and well-tolerated and provided plasma drug levels that were seven-fold and 13-fold, respectively, over the plasma protein adjusted EC₉₀ for the Omicron variant, without the need for a boosting agent such as ritonavir and its associated drug-drug interactions.”