AIM ImmunoTech completes treatment of last subject in Phase 2 study of Ampligen

AIM ImmunoTech announced the last subject has completed treatment in the Company’s Phase 2 study evaluating Ampligen as a potential therapeutic for people with the Post-COVID condition of fatigue. As previously announced, the Company completed enrollment in the AMP-518 study in August 2023. Approximately 80 subjects, ages 18 to 60 years, were enrolled and randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. To date, no severe adverse events have been reported. The Company remains on track to report topline data as early as Q1 2024. The AMP-518 clinical trial is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in subjects experiencing the post-COVID condition of fatigue. The primary protocol planned outcome measure of the study is change from baseline to week 13 in PROMIS Fatigue Score. Other protocol planned study outcomes include: change from baseline to week 6 in PROMIS Fatigue Score; change from baseline to weeks 6 and 13 in distance traveled during a Six-Minute Walk Test; proportion of subjects that surpass 54 meters in the Six-Minute Walk Test at the end of 12-week treatment phase; change from baseline to weeks 6 and 13 in PROMIS Cognitive Function Score; and change from baseline to weeks 6 and 13 in PROMIS Sleep Disturbance Score.