AIM ImmunoTech Enrolls and Doses First Subject in Phase 2 Study Evaluating Ampligen® for the Treatment of Post-COVID Conditions

Preliminary Ampligen data demonstrates potential to be an effective treatment option for post-COVID conditions

Enrollment expected to be completed in Q4 2023

OCALA, Fla., July 10, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM”) today announced it has enrolled and dosed the first subject in the company’s Phase 2 study evaluating Ampligen^® as a potential therapeutic for people with post-COVID conditions ("AMP-518”). This important study milestone follows on the heels of the company having recently opened multiple clinical study sites and having screened numerous subjects. Study screening is ongoing and AIM expects to dose additional new subjects in the coming weeks. For more information about AMP-518, please visit ClinicalTrials.gov and reference identifier NCT05592418.

AIM Chief Executive Officer Thomas K. Equels commented, "We have clinical sites up and running, and we expect additional sites to be open in the very near future. AIM knows how vital it is to keep building on this momentum. By developing Ampligen as a therapeutic for Long COVID with chronic fatigue-like symptoms, we are working to bring hope to the millions of people struggling with this debilitating and life-altering syndrome. Long COVID is a major unmet medical need — in other words, there is no approved therapy available for this major health problem, and we believe that Ampligen has the potential to be a therapeutic solution.”

Oved Amitay, President and CEO of the national advocacy organization Solve M.E., commented, "Post-COVID conditions are a looming public health crisis. The CDC estimates that 1.6% of adults in the U.S. are struggling with significant activity limitations from Long COVID, presenting extreme challenges for patients, their caregivers and families. We are encouraged by the progress of the AMP-518 clinical study, and the potential for this therapeutic to address debilitating aspects of these conditions and to bring hope to the millions of people affected by Long COVID, as well as the many other people suffering from associated conditions such as myalgic encephalomyelitis, also known as chronic fatigue syndrome or ME/CFS.”

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.

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. Subjects 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.

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.

For more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook.

About Solve M.E.

The Solve ME/CFS Initiative (Solve M.E.) is a non-profit organization that serves as a catalyst for critical research into diagnostics, treatments and cures for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), Long COVID and other post-infection diseases. Solve M.E.’s. work with the scientific, medical, and pharmaceutical communities; advocacy with government agencies; and alliances with patient groups around the world is laying the foundation for breakthroughs that can improve the lives of millions who suffer from various "long haul” diseases.

Cautionary Statement

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 information relied upon for this Study is primarily derived from preliminary data from a small number of subjects. Significant additional testing and trials will be required to determine whether Ampligen^® will be effective in the treatment Post-COVID. No assurance can be given as to whether the Phase 2 Study will be successful or yield favorable data or require additional funding. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.