Benzinga | Sep 21, 2021 07:26AM EDT

AIM ImmunoTech Says FDA Meeting Request Has Been Deemed Sufficient For Transfer To FDA's Division Of Neurology

AIM ImmunoTech Inc. (NYSE:AIM) today announced positive progress with the company's meeting request to the U.S. Food and Drug Administration (FDA) 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.



"We are pleased with this next step -- the referral to the FDA's Division of Neurology -- as our focus is on the brain-related symptoms of Long COVID," said AIM CEO Thomas K. Equels.

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.

Dr. Kazem Kazempour, Amarex Clinical Research CEO, added, "We requested the FDA meeting to consult on the regulatory strategy for this treatment as a central nervous system product. FDA alignment with the strategy illustrates a positive step forward in finding a treatment for PCCD. Moreover, it is both exciting and gratifying to be working on this product for AIM. This is a new and serious COVID-induced disease indication for which there is currently no treatment."