AIM ImmunoTech Inc. announced positive topline results from the Company's Phase 2 study evaluating the efficacy and safety of Ampligen®? as a potential therapeutic for people with the Post-COVID condition of fatigue ("AMP-518"). The AMP-518 clinical trial was a two-arm, randomized, double-blind, placebo-controlled, multicenter study.

The primary outcome measure is change from baseline to week 13 in PROMIS®? Fatigue Score. Although the reduction in that measure did not show a significant difference at the 13-week time point, initial analysis revealed that subjects in the Ampligen group had experienced lower levels of fatigue at multiple time points during the treatment phase when compared to the placebo group.

An analysis of secondary and ad hoc endpoints found that the difference in change from baseline in PROMIS®? fatigue Score between the Ampligen and placebo groups reached or approached statistical significance at several timepoints during the treatment phase. Demographics and baseline characteristics were generally comparable between the Ampligen and placebo group.

Additionally, the analysis of safety parameters demonstrated that Ampligen was generally well-tolerated with no severe adverse events, no treatment-emergent adverse events (TEAEs) leading to death, and no severe TEAEs reported during the study. There were six subjects (15.0%) in the Ampligen group with TEAEs considered related to the study treatment, the majority of which were mild in severity. More subjects in the Ampligen group compared to the placebo group reported TEAE (10 subjects, 25.0% vs.

four subjects, 10.0%), however the majority of these were mild.