OCALA, Fla., April 04, 2023 — AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, today announced central Institutional Review Board (“IRB”) approval for the protocol of its Phase 2 study evaluating Ampligen® 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® 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 6 and 13 in PROMIS® Cognitive Function Score; and change from baseline to weeks 6 and 13 in PROMIS® Sleep Disturbance Score.
AIM Chief Executive Officer Thomas K. Equels commented, “This is an important step forward in the development of Ampligen as a potential therapeutic for the treatment of post-COVID chronic fatigue-like conditions. We continue to be encouraged by the pilot data demonstrated to date and believe Ampligen has the potential to meet an important growing unmet medical need, with a patient population that exceeds several million in the United States alone, with even more worldwide. With central IRB approval, our team is working toward getting our pre-selected sites open so that patient enrollment and dosing can be up and running as quickly and efficiently as possible.”
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 Q2 2023.
For more information about AMP-518 please visit ClinicalTrials.gov and reference identifier NCT05592418.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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