OCALA, Fla., May 18, 2022 — 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 provided an update on its ongoing efforts to develop an effective therapeutic for “Long COVID” with its investigational drug, Ampligen.
Long COVID – also referred to as Post-COVID conditions by the U.S. Centers for Disease Control and Prevention (CDC) – presents as a wide range of health problems. The CDC’s current list of Post-COVID conditions includes 18 different health issues. Approximately one-half of these overlap with symptoms seen in patients with Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). SARS-related diseases have a history of inducing similar symptoms (See: JAMA).
A Phase 3 prospective, double-blind, randomized, placebo-controlled trial of rintatolimod (Ampligen) in ME/CFS (AMP-516) produced objective improvement in exercise tolerance. An analysis of a subset of patients in that trial with early onset of symptoms showed a statistically significant 51.2% positive response (p=0.003) (See: PLOS ONE).
In an amendment to its ongoing, FDA-authorized AMP-511 (See: ClinicalTrials.gov) expanded access program (EAP), AIM enrolled four post-COVID patients with new onset ME/CFS following acute COVID-19. Following at least 12 weeks of Ampligen treatment, each of these four patients indicated they had experienced a reduction in fatigue, as measured via Patient-Reported Outcomes questionnaires. A statistical analysis of these data indicated that the decrease in fatigue compared to baseline was statistically significant (p<0.003), despite the small number of patients.
Based in part on these early positive data, AIM is working toward filing an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for a Phase 2 study of Ampligen for the treatment of Post-COVID conditions. The newly planned IND is for 12 weeks of therapy.
AIM Chief Medical Officer David Strayer, MD, stated: “AIM believes these results are especially encouraging and justify conducting a placebo-controlled study to attempt to confirm these findings. Evidence from the AMP-516 study indicated that severe ME/CFS patients with a shorter time from onset of ME/CFS symptoms as a group responded better than those with a longer duration of illness. Although the time scale is much more condensed, the results from these four patients indicating improvement in fatigue in only 12 weeks is consistent with the hypothesis that a shorter duration of illness prior to treatment may improve responses to Ampligen.”
Charles Lapp, MD, Principal Investigator for AMP-511 at Hunter-Hopkins Center in Charlotte, N.C., stated: “Four subjects with Long COVID – or Post-Acute Sequelae of Covid (PASC) – have shown significant improvement in fatigue and their ability to be active, as measured by an 11-point Likert scale. Three of the four have also reported improvement in their post-exertion malaise. The results have been so successful that two have asked to continue Ampligen therapy. I have been very pleased with these results and see potential for the therapeutic benefit of Ampligen in other persons with Long COVID. I am excited to move forward with a larger study of Ampligen for Long Haulers (PASC).”
Oved Amitay, President and CEO of the advocacy organization Solve M.E., stated: “Long COVID is a public health crisis and patients are struggling to access safe and effective therapeutics. We are encouraged that AIM ImmunoTech is engaging with the patient communities to learn about their unmet needs. We are hopeful about the potential of the drug Ampligen in Long COVID and ME/CFS. There is a great interest in the study because drugs that combat viruses, as well as affecting the immune system, could provide a significant benefit to people with these post-infection diseases. The FDA must work with drug developers and patient advocates to enable the rapid initiation of these important studies on this and other promising treatments.”
AIM CEO Thomas K. Equels stated: “While the recently published positive data in pancreatic cancer, advanced recurrent ovarian cancer and triple-negative breast cancer make Ampligen in oncology a top priority, we remain dedicated in our efforts to develop an effective therapy for ME/CFS and Long COVID. Millions of people have suffered too long from these debilitating conditions, and we are steadfast in our mission to help alleviate their suffering.”
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.
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. Studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be an effective treatment for Long COVID. Additionally, there is no guarantee as to when or whether an IND application will be submitted to the U.S. Food and Drug Administration, nor, if an application is submitted, whether it will be accepted.
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