AIM ImmunoTech Inc has progressed a step further in its bid to get Ampligen into a clinical trial to test it as an infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD) – a new and serious coronavirus-induced disease for which there is currently no treatment.
The FDA has deemed a meeting request sufficient for transfer now to the regulator’s Division of Neurology by the FDA’s Covid scientific technical triage team.
The planned Phase 2 randomized, double blind, placebo controlled, multicenter study will be managed by Amarex Clinical Research and is designed to evaluate the efficacy and safety of Ampligen in patients experiencing PCCD.
READ: AIM ImmunoTech offers a status update on its pending Phase 2a Human Challenge Trial using its flagship drug Ampligen
“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 in a statement.
The trial will see 80 patients randomized 1:1 to receive twice-weekly infusions of Ampligen or placebo for 12 weeks.
Dr. Kazem Kazempour, Amarex Clinical Research CEO, added: “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.”
AIM ImmunoTech Inc is focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.
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Story by ProactiveInvestors
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