AIM ImmunoTech Inc. 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 (AMP-518). 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 first quarter 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.