Tuesday, July 11, 2023
AIM ImmunoTech Inc. (NYSE American: AIM) has announced the enrollment and dosing of the first participant in their Phase 2 study, AMP-518, which examines the potential therapeutic benefits of Ampligen® for individuals with post-COVID conditions. This significant milestone follows the recent establishment of multiple clinical study sites and ongoing participant screening. AIM anticipates dosing additional subjects in the coming weeks. To access more information about AMP-518, please visit ClinicalTrials.gov and refer to the identifier NCT05592418.
CEO of AIM, Thomas K. Equels, emphasized the importance of building on the current momentum, stating, We have clinical sites up and running, and we expect additional sites to be open in the very near future. AIM knows how vital it is to keep building on this momentum. By developing Ampligen as a therapeutic for Long COVID with chronic fatigue-like symptoms, we are working to bring hope to the millions of people struggling with this debilitating and life-altering syndrome. Long COVID is a major unmet medical need — in other words, there is no approved therapy available for this major health problem, and we believe that Ampligen has the potential to be a therapeutic solution.
Oved Amitay, President and CEO of the national advocacy organization Solve M.E., expressed optimism about the progress of the AMP-518 clinical study and its potential impact on individuals affected by post-COVID conditions. Amitay acknowledged the significant public health crisis presented by post-COVID conditions, with a considerable number of adults in the U.S. facing challenges related to Long COVID and associated conditions such as myalgic encephalomyelitis, also known as chronic fatigue syndrome or ME/CFS.
The AMP-518 clinical trial is a randomized, double-blind, placebo-controlled study taking place at multiple centers in the United States. It aims to evaluate the efficacy and safety of Ampligen in individuals experiencing post-COVID fatigue. The primary outcome measure of the study is the change in PROMIS® Fatigue Score from baseline to week 13. Other planned outcomes include changes in PROMIS® Fatigue Score at week 6, distance traveled during a Six-Minute Walk Test at weeks 6 and 13, proportion of subjects surpassing 54 meters in the Six-Minute Walk Test at the end of the 12-week treatment phase, changes in PROMIS® Cognitive Function Score at weeks 6 and 13, and changes in PROMIS® Sleep Disturbance Score at weeks 6 and 13.
AMP-518 is expected to enroll around 80 participants aged 18 to 60 years across up to 10 centers in the United States. Participants will be randomly assigned in a 1:1 ratio to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, followed by a two-week follow-up period.