AIM ImmunoTech Inc (NYSE:AIM) 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 (NYSE:AIM) 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.
Shares nudged up 2.5% in New York to stand at US$2.03.
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Contact the author at giles@proactiveinvestors.com