AIM ImmunoTech Inc. announced central Institutional Review Board ("IRB") approval for the protocol of its Phase 2 study evaluating Ampligen(R) as a therapeutic for patients with post-COVID conditions ("AMP-518"). With this approval in hand, AIM is moving forward with the start-up process for the study's planned clinical sites. The AMP-518 clinical trial is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in patients experiencing the post-COVID condition of fatigue.

The primary outcome measure of the study is change from baseline to week 13 in PROMIS(R) Fatigue Score. Other 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 six and 13 in PROMIS(R) Cognitive Function Score; and change from baseline to weeks 6 & 13 in PROMIS(S) Sleep Disturbance Score.

AMP-518 is expected to enroll approximately 80 subjects between the ages of 18 to 60 years across up to 10 centers in the United States. Patients will be randomized 1:1 to receive twice weekly IV infusions of Ampligen or placebo for 12 weeks with a follow up phase of two weeks. The Company expects to begin patient enrollment and dosing in the AMP-518 study in second quarter 2023.