AIM AIM ImmunoTech Inc

AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today offered commentary on a new article in the Journal of General Internal Medicine linking COVID-19 to increased risk of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”).

The article, titled “Incidence and Prevalence of Post-COVID-19 Myalgic Encephalomyelitis: A Report from the Observational RECOVER-Adult Study,” found that among study participants infected with SARS-CoV-2, the incidence of ME/CFS was 15 times higher than pre-pandemic rates. The article’s lead author, Suzanne D. Vernon, PhD, emphasized the following highlights in an accompanying analysis posted to the Bateman Horne center website:

• Of the 4,515 participants who enrolled within 30 days of contracting COVID-19, 73 developed ME/CFS at least six months post-infection.
• In total, 531 participants met ME/CFS criteria, translating to a prevalence of 4.5% among those infected—nearly eight times higher than uninfected participants.
• This prevalence is five times higher than pre-pandemic estimates and underscores the severe and lasting impact of COVID-19 on public health.
• 90% of these post-COVID-19 ME/CFS cases clustered with the most symptomatic and severe cases of Long COVID, highlighting the overlap between these two conditions.

Dr. Vernon stated in her commentary: “This finding reinforces what we at [Bateman Horne Center] have long known: ME/CFS is not only a real and diagnosable condition, but it is also a disabling disease that demands attention, especially in the wake of a global pandemic.”

Ampligen in ME/CFS and Long COVID

This new detailed analysis supports AIM’s scientific and business decision to emphasize the development of its drug Ampligen as a treatment for people suffering from ME/CFS symptoms post-COVID-19. AIM had extensive experience with ME/CFS prior to the COVID-19 pandemic and was able to quickly pivot to research and clinical studies on Long COVID; the RECOVER ME/CFS data supports this move. In September 2024, AIM announced that analysis of the complete clinical patient data from its AMP-518 clinical program supported the Company’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue, and that this would therefore likely be the subject population for a planned follow-up clinical trial.

AMP-518 analysis determined that study patients with Long COVID were, on average, able to walk farther in a Six-Minute Walk Test (“6MWT”) when compared to subjects who received a placebo. The 6MWT measured the distance a subject was able to walk in six minutes as a baseline and then again at 13 weeks. A clear signal of significant potential (p <0.02, two-tailed T-test) was observed in Ampligen-treated subjects with a baseline 6MWT less than 205 meters, who saw a mean improvement of 139 meters, compared to a mean improvement of 91 meters in the corresponding part of the group who received the placebo. AIM therefore believes that any future trial design should focus on Ampligen’s therapeutic potential for subjects who’s Long COVID-related fatigue can be categorized as moderate or worse.

AIM CEO Thomas K. Equels stated: “Based on our previous data of Ampligen in ME/CFS and the strong similarities to long-term symptoms of COVID, expanding the use of Ampligen for the treatment of Long COVID was a natural next step. That expansion of our pipeline of studies at the onset of the pandemic has proven to be a successful venture with the positive results from our Phase 2 study of people with the Post-COVID condition of fatigue. We continue to be encouraged by Ampligen’s ability to improve measures of fatigue and believe that these advances will translate into advancement in the treatment of ME/CFS given the high correlation of symptoms with Long COVID. The recently published article further supports the link between Long COVID and the incidence of ME/CFS, and bolsters our confidence in the potential of Ampligen to address this growing unmet need.”

Ampligen as an Early-Onset Therapy

Data published in PLOS One in 2020 detailed how Ampligen could have a considerable positive impact on people living with ME/CFS when administered in the early stages of the disease. The ME/CFS population of 208 subjects was divided into two subsets based on symptom duration. The Target subset consisting of 75 patients with ME/CFS symptom duration of 2-8 years was compared to a Non-Target subset consisting of 133 patients with symptom duration outside of the 2-8-year range.

The placebo-adjusted percentage increase in Exercise Treadmill Testing (“ETT”) and the vertical rise in feet while exercising on the treadmill in the Target subset were both at least twice that seen for the combined population of 208 subjects. While no clinically significant ETT response was seen in the Non-Target subset, within the Target subset, 51.2% of the Ampligen-treated subjects improved their exercise duration by at least 25% (p=0.003, a statistically significant value). This magnitude of exercise improvement was associated with additional measures of improved quality of life, including an ability to ascend the equivalent of nearly 175 more vertical feet at Week 40 when compared to the baseline value before the Ampligen treatment was started. The analysis indicates that there may be a relatively short disease duration window early in the course of the disease (before eight years) in which ME/CFS patients may see a significant clinical response.

Equels states: “Early treatment may make a life-changing difference. We cannot afford to lose another generation to the ravages of ME/CFS.”

AIM Consulting Medical Officer Charles Lapp, MD, stated: “The PLOS One data demonstrated the potential for a significant therapeutic advantage for ME/CFS patients who receive Ampligen in the earlier stages of the disorder. This would be especially significant for those suffering most severely, as ME/CFS can become totally debilitating for many sufferers. We are seeing the same severe symptoms with Long COVID. This strongly suggests that the earlier Ampligen is administered as a therapeutic to both ME/CFS and Long COVID patients, the better the patients’ chances will be.”

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 in clinical trials 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 X, LinkedIn, and Facebook.

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,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon 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. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy for ME/CFS or the Post-COVID Condition of Fatigue. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the 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.

Investor Contact:

JTC Team, LLC
Jenene Thomas
908.824.0775
AIM@jtcir.com