ENU200 / Ennaid Therap, Catalent - LARVOL DELTA

Ennaid Therapeutics announces development of ENU200, a new antiviral therapeutic for the treatment of Covid-19 (PRNewswire) - "Ennaid Therapeutics, LLC...today announced that it is advancing the development of ENU200, as a therapeutic to treat the up to 80% of asymptomatic, mild to moderate cases of COVID-19 viral infections....Utilizing the FDA's emergency/compassionate use regulatory pathway, or the FDA's 505(b)(2) application process, Ennaid believes it can quickly bring ENU200 to market by treating patients with COVID-19 in a Phase 3 in-home, self-dosing clinical trial of patients....Ennaid is currently in discussions with the FDA and other regulatory agencies around the world regarding the planned clinical trial, which if approved, could enable ENU200 to be available to patients in six to nine months."

New P3 trial • Non-US regulatory • Regulatory