AIM ImmunoTech Announces FDA Clearance of IND Application to Evaluate Ampligen® in Phase 2 Clinical Study for the Treatment of Post-COVID Conditions

Company expects to commence patient enrollment and dosing in Q1 2023

OCALA, Fla., Oct. 12, 2022 (GLOBE NEWSWIRE) -- 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, including COVID-19, the disease caused by the SARS-CoV-2 virus, today announced its Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) may proceed to initiate a Phase 2 study evaluating its investigational drug, Ampligen, as a therapeutic for patients with post-COVID conditions ("AMP-518”). AIM has pending patent applications for compositions and methods for treating post-COVID conditions with a composition comprising Ampligen.

"We are very pleased to be able to proceed with our Phase 2 study and are prepared to advance Ampligen as a potential therapeutic for the treatment of myalgic encephalomyelitis/chronic fatigue (ME/CFS)-like post-COVID conditions, an exploding area of significant unmet medical need,” commented Thomas K. Equels, MS JD, Chief Executive Officer of AIM. "Post-COVID-19 Disabling Fatigue, along with other debilitating post-COVID conditions such as ‘Brain Fog’, continue to affect tens of millions of people worldwide. Based on the preliminary uncontrolled clinical data flowing from our AMP-511 study and the antiviral activity we have seen to date, we believe Ampligen has the potential to be an effective treatment option and an important solution for patients and physicians. We are deeply grateful for the FDA’s regulatory guidance related to this important clinical trial and with the IND clearance now in hand, our team is working to get the study up and running as quickly and efficiently as possible. We expect to commence enrollment in early 2023.”

Oved Amitay, PhD, President and CEO of the advocacy organization Solve M.E. added, "Post-COVID conditions continue to present as a serious public health crisis and there remains an ongoing struggle for patients to access safe and effective therapeutics. To address this unmet need, it is critical that we apply existing knowledge, such as studies done previously in ME/CFS. In the AMP-516 study in people with ME/CFS, Ampligen has demonstrated an encouraging safety profile and was well tolerated, and data in post-COVID from the AMP-511 study shows a similar profile. Additionally, the data published in the PLOS ONE paper from a subgroup analysis in the AMP-516 study showed a response rate greater than 50%, a statistically significant response in people who were treated closer to the onset of their disease. I am therefore hopeful about the potential of Ampligen for post-COVID conditions given the possibility of an earlier intervention and believe that this study is an important step in addressing the needs of people with these post-infection debilitating symptoms.”

The planned Phase 2 study 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 week 6 and 13 in distance traveled during a 6-minute walk test; proportion of subjects with minimal clinically important difference, defined as at least 54 meters, in the Six-Minute Walk Test at the end of 12-week treatment phase; change from baseline to week 6 and 13 in PROMIS^® Cognitive Function Score; change from baseline to week 6 and 13 in PROMIS^® Sleep Disturbance Score; and change from baseline to week 6 and 13 in 36-Item Short Form Survey.

Approximately 80 subjects between the ages of 18 to 60 years old are expected to be enrolled 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 2 weeks. The Company expects to commence patient enrollment and dosing in the AMP-518 study in Q1 2023.

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, Ampligen^® (rintatolimod) is an immuno-modulator with broad spectrum activity being developed 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 and their absence does not mean that a statement is not forward-looking. Many of these forward-looking statements involve a number of risks and uncertainties. For instance, while preliminary data in the small number of subjects shows significance, no assurance can be given that the findings in the small study supporting the planned Phase 2 clinical trial will prove true or that the Phase 2 clinical trial will yield favorable results. Significant additional testing and trials will be required to determine whether Ampligen will be an effective treatment for Long COVID. 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.