AIM ImmunoTech Receives Positive FDA Response For Ampligen Trial In PCCD Patients

AIM ImmunoTech Inc AIM has announced positive progress with the FDA meeting request concerning a Phase 2 study of Ampligen 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.
Related Link: AIM ImmunoTech To Test Ampligen In Post-COVID-19 Cognitive Dysfunction.
"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 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.
Price Action: AIM stock is up 3.03% at $2.04 during the market session on the last check Tuesday.