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

© Provided by Benzinga AIM ImmunoTech Inc (NYSE: 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.

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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