AIM Immunotech Announces Positive Progress on Requested FDA Meeting for Proposed Ampligen Clinical Trial in Post-Covid-19 Cognitive Dysfunction
September 21, 2021 at 07:25 am EDT
AIM ImmunoTech Inc. announced positive progress with the company’s meeting request to the U.S. Food and Drug Administration concerning a Phase 2 clinical study of Ampligen as an infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD). The meeting request has been deemed sufficient for transfer to the FDA’s Division of Neurology by the FDA’s Covid Scientific Technical Triage Team. The planned Phase 2, two-arm, randomized, double blind, placebo controlled, multicenter study is designed to evaluate the efficacy and safety of Ampligen in patients experiencing PCCD. Eighty subjects will be randomized 1:1 to receive twice weekly infusions of Ampligen or placebo for a period of 12 weeks. Amarex Clinical Research, an NSF International company, will manage the clinical trial.