OCALA, Fla., Oct. 12, 2022 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE: American AIM) (“AIM” or the “Company”), an immuno-pharma firm centered on the analysis and growth of therapeutics to deal with a number of varieties of cancers, immune issues, and viral ailments, together with COVID-19, the illness brought on by the SARS-CoV-2 virus, in the present day introduced its Investigational New Drug (IND) utility filed with the U.S. Food and Drug Administration (FDA) could proceed to provoke a Phase 2 examine evaluating its investigational drug, Ampligen, as a therapeutic for sufferers with post-COVID situations (“AMP-518”). AIM has pending patent purposes for compositions and strategies for treating post-COVID situations 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 Okay. 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 group 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 deliberate Phase 2 examine is a two-arm, randomized, double-blind, placebo-controlled, multicenter examine to judge efficacy and security of Ampligen in sufferers experiencing the post-COVID situation of fatigue. The main consequence measure of the examine is change from baseline to week 13 in PROMIS® Fatigue Score. Other examine outcomes embody: change from baseline to week 6 in PROMIS® Fatigue Score; change from baseline to week 6 and 13 in distance traveled throughout a 6-minute stroll take a look at; proportion of topics with minimal clinically essential distinction, outlined as a minimum of 54 meters, within the Six-Minute Walk Test on the finish of 12-week therapy section; 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 alter from baseline to week 6 and 13 in 36-Item Short Form Survey.
Approximately 80 topics between the ages of 18 to 60 years previous are anticipated to be enrolled throughout as much as 10 facilities within the United States. Patients can be randomized 1:1 to obtain twice weekly IV infusions of Ampligen or placebo for 12 weeks with a observe up section of 2 weeks. The Company expects to begin affected person enrollment and dosing within the AMP-518 examine in Q1 2023.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma firm centered on the analysis and growth of therapeutics to deal with a number of varieties of cancers, immune issues, and viral ailments, together with COVID-19. The Company’s lead product, Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum exercise being developed for globally essential cancers, viral ailments and issues of the immune system.
For extra data, please go to aimimmuno.com and join with the Company on Twitter, LinkedIn, and Facebook.
About Solve M.E.
The Solve ME/CFS Initiative (Solve M.E.) is a non-profit group that serves as a catalyst for essential analysis into diagnostics, therapies, and cures for myalgic encephalomyelitis/power fatigue syndrome (ME/CFS), Long COVID and different post-infection ailments. Solve M.E’s. work with the scientific, medical, and pharmaceutical communities, advocacy with authorities businesses, and alliances with affected person teams all over the world is laying the inspiration for breakthroughs that may enhance the lives of tens of millions that suffer from varied “long haul” ailments.
Cautionary Statement
This press launch incorporates forward-looking statements throughout the which means of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words similar to “may,” “will,” “expect,” “plan,” “anticipate” and comparable expressions (in addition to different phrases or expressions referencing future occasions or circumstances) are supposed to establish forward-looking statements and their absence doesn’t imply {that a} assertion just isn’t forward-looking. Many of these forward-looking statements contain a quantity of dangers and uncertainties. For occasion, whereas preliminary information within the small quantity of topics exhibits significance, no assurance might be provided that the findings within the small examine supporting the deliberate Phase 2 scientific trial will show true or that the Phase 2 scientific trial will yield favorable outcomes. Significant extra testing and trials can be required to find out whether or not Ampligen can be an efficient therapy for Long COVID. Among different issues, for these statements, the Company claims the safety of protected harbor for forward-looking statements contained within the PSLRA. The Company doesn’t undertake to replace any of these forward-looking statements to replicate occasions or circumstances that happen after the date hereof.
