AIM ImmunoTech announces completion of enrollment in Phase 2 study of Ampligen

AIM ImmunoTech announced the completion of enrollment in the company’s Phase 2 study evaluating Ampligen(R) as a potential therapeutic for people with post-COVID conditions. The study has met the planned enrollment of 80 AMP-518 subjects ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. The company expects to complete dosing of the last study patient in Q4 2023. Topline data is expected as early as Q1 2024. Oved Amitay, President and CEO of the national advocacy organization Solve M.E., commented, “The CDC estimates that approximately four million Americans are struggling with significant activity limitations from Long COVID, presenting extreme challenges for patients, their caregivers and their families. Complete AMP-518 study enrollment is a critical step in the ongoing effort to develop Ampligen as a therapeutic to address the debilitating aspects of Long COVID and to bring hope not only to the millions of people affected by this disease, but also to the many people suffering from associated conditions such as myalgic encephalomyelitis, also known as chronic fatigue syndrome or ME/CFS.”