AIM ImmunoTech reports topline results from Phase 2 study of Ampligen

AIM ImmunoTech announced 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. 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. The Six-Minute Walk Test also revealed a higher impact of Ampligen on distance traveled in six minutes at Week 13 compared to placebo. Eighty subjects were enrolled in AMP-518, and forty were randomized to each treatment group. Of the 80 enrolled subjects, 66 subjects completed the treatment, which consisted of 36 subjects in the Ampligen group and 30 subjects in the placebo group. The primary reasons for discontinuation from treatment included withdrawal by subject, lost to follow-up, and adverse event. Demographics and baseline characteristics were generally comparable between the Ampligen and placebo groups. Additionally, the analysis of safety parameters demonstrated that Ampligen was generally well-tolerated with no severe adverse events, no treatment-emergent adverse events leading to death, and no severe TEAEs reported during the study. There were six subjects in the Ampligen group with TEAEs considered related to the study treatment, the majority of which were mild in severity. Two subjects in the Ampligen group had TEAEs leading to treatment discontinuation or interruption. More subjects in the Ampligen group compared to the placebo group reported TEAE, however the majority of these were mild.