On Sept. 8, 2021, AIM ImmunoTech announced that is had submitted a Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of Ampligen as a potential infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD).

This will be a Phase 2, two-arm, randomized, double blind, placebo controlled, multicenter study 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, is managing the FDA submission and will manage the clinical trial.

Developing an effective therapy is critical for relieving the socioeconomical impact of PCCD and its medical burden on the U.S. and global populations. People suffering from PCCD – including young adults – can suffer severe difficulties in concentrating, serious memory problems and inability to live an active lifestyle, unable to work, and even unable to perform everyday tasks.