Topline data expected as early as Q1 2024
OCALA, Fla., Aug. 08, 2023 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced the completion of enrollment in the company’s Phase 2 study evaluating Ampligen® as a potential therapeutic for people with post-COVID conditions (“AMP-518”).
The study has met the planned enrollment of 80 AMP-518 subjects ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. The company expects to complete dosing of the last study patient in Q4 2023. Topline data is expected as early as Q1 2024.
AIM Chief Executive Officer Thomas K. Equels commented, “We are incredibly pleased with the extremely rapid pace of enrollment for AMP-518. The completion of enrollment in such a short timeframe highlights the unmet medical need for a therapeutic option to treat Long COVID with chronic fatigue-like symptoms. We continue to be encouraged by the potential of Ampligen and are working diligently to bring this study across the finish line with the ultimate goal of helping the millions of people struggling with this debilitating and life-altering syndrome.”
Oved Amitay, President and CEO of the national advocacy organization Solve M.E., commented, “The CDC estimates that approximately four million Americans are struggling with significant activity limitations from Long COVID, presenting extreme challenges for patients, their caregivers and their families. Complete AMP-518 study enrollment is a critical step in the ongoing effort to develop Ampligen as a therapeutic to address the debilitating aspects of Long COVID and to bring hope not only to the millions of people affected by this disease, but also to the many 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.
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 for globally important cancers, viral diseases and disorders of the immune system.
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.
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 of Post-COVID conditions. 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.
CONTACT: Investor Relations Contact JTC Team, LLC Jenene Thomas 833-475-8247 [email protected]