AIM ImmunoTech Provides Update on Ampligen Long COVID Development Program | News

OCALA, Fla., May 18, 2022 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE: American AIM) (“AIM” or the “Company”), an immunopharmaceutical company focused on researching and developing therapies to treat multiple types cancers, immune disorders and viral illnesses, including COVID-19, the disease caused by the SARS-CoV-2 virus, today provided an update on its ongoing efforts to develop an effective treatment for the “Long COVID” with its experimental drug, Ampligen.

The long COVID – also called post-COVID conditions by the US Centers for Disease Control and Prevention (CDC) – presents itself as a wide range of health problems. The CDC’s current list of post-COVID conditions includes 18 different health conditions. About half of these symptoms overlap with the symptoms seen in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). SARS-related illnesses have a history of inducing similar symptoms (see: JAMA ).

A prospective Phase 3, 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 this trial with early onset symptoms showed a statistically significant positive response of 51.2% (p=0.003) (see: PLOS ONE ).

In an amendment to its pending FDA-cleared AMP-511 (see: ClinicalTrials.gov ) Expanded Access Program (EAP), AIM recruited four post-COVID patients with new-onset ME/CFS following acute COVID-19. After at least 12 weeks of treatment with Ampligen, each of these four patients reported experiencing a reduction in fatigue, as measured via Patient-Reported Outcomes questionnaires. Statistical analysis of these data indicated that the decrease in fatigue from baseline was statistically significant (p

Based in part on this positive early data, AIM is working to file 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 12 weeks of treatment.

AIM Medical Director David Strayer, MD said, “AIM believes these results are particularly encouraging and warrant the conduct of a placebo-controlled study to attempt to confirm these results. Evidence from the AMP-516 study indicated that patients with severe ME/CFS with shorter time since onset of ME/CFS symptoms as a group responded better than those whose disease was longer. Although the timescale is much more condensed, the results from these four patients showing improvement in fatigue in just 12 weeks is consistent with the hypothesis that shorter duration of illness before treatment may improve responses. in Ampligen.

Charles Lapp, MD, principal investigator for AMP-511 at the Hunter-Hopkins Center in Charlotte, North Carolina, said, “Four subjects with long COVID – or post-acute sequelae of Covid (PASC) – showed significant improvement in fatigue and their ability to be active, as measured by an 11-point Likert scale.Three of the four also reported an improvement in their post-exercise discomfort.The results were so successful that two of between them have asked to continue treatment with Ampligen. I have been very pleased with these results and see the potential for the therapeutic benefits of Ampligen in other people with Long COVID. I am excited to move forward. forward with a larger study on Ampligen for Long Haulers (PASC).”

Oved Amitay, President and CEO of advocacy organization Solve ME, said: “Long COVID is a public health crisis and patients are struggling to access safe and effective therapies. We are encouraged that AIM ImmunoTech is engaging with patient communities to learn more about their unmet needs. We are hopeful about the potential of the drug Ampligen in Long COVID and ME/CFS. The study is of great interest because drugs that fight viruses, in addition to affecting the immune system, could provide significant benefit to people with these post-infectious diseases. The FDA needs to work with drug developers and patient advocates to enable these important studies of this and other promising treatments to get started quickly.

AIM CEO Thomas K. Equels said, “While the positive data recently released in pancreatic cancer, advanced recurrent ovarian cancer and triple negative breast cancer making 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 from these debilitating conditions for far too long, and we are steadfast in our mission to help alleviate their suffering.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immunopharmaceutical company focused on the research and development of therapeutic products to treat several types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product, Ampligen® (rintatolimod), is a broad-spectrum immunomodulator in development for cancers, viral diseases and immune system disorders of global importance.

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

Caution

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”, “shall”, “expect”, “plan”, “anticipate” and similar expressions (as well as other words or expressions referring to future events or circumstances) are intended identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for these statements, the Company claims safe harbor protection for forward-looking statements contained in the PSLRA. The Company undertakes no obligation to update 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 changing priorities at institutions sponsoring other trials. Significant additional testing and trials will be needed to determine if Ampligen will be an effective treatment for long COVID. Further, there is no guarantee as to when or if an IND request will be submitted to the United States Food and Drug Administration, or, if a request is submitted, whether it will be accepted.

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