AIM ImmunoTech Announces Publication of Final Clinical Study Results for AMP-518 Clinical Trial on Ampligen as a Therapeutic for Post-COVID Conditions
Rhea-AI Summary
AIM ImmunoTech (NYSE American: AIM) has published final clinical study results for its AMP-518 Phase 2 trial evaluating Ampligen as a treatment for Post-COVID conditions. The study showed promising results, particularly for patients with moderate-to-severe Post-COVID fatigue.
Key findings revealed that Ampligen-treated patients with Long COVID demonstrated improved walking capacity compared to placebo groups. Specifically, patients with a baseline Six-Minute Walk Test (6MWT) less than 205 meters showed significant improvement, achieving a mean increase of 139 meters versus 91 meters in the placebo group (p <0.02).
The company highlighted recent NIH RECOVER initiative data showing that ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) prevalence is now five times higher than pre-pandemic levels due to COVID-19 infections. Based on these results, AIM plans to conduct a follow-up clinical trial focusing on patients with moderate or worse COVID-related fatigue or ME/CFS symptoms.
Positive
- Significant improvement in walking capacity for Ampligen-treated patients (139m vs 91m in placebo)
- Statistical significance achieved (p<0.02) in patients with baseline 6MWT below 205 meters
- Clear identification of target patient population for future trials
Negative
- Benefits to specific patient subset (those with baseline 6MWT <205 meters)
- Additional clinical trials required before potential commercialization
Insights
The final results of AIM ImmunoTech's AMP-518 trial reveal a strategically significant development in the post-COVID therapeutic landscape. The trial's focus on the Six-Minute Walk Test (6MWT) is particularly noteworthy, as it's a well-validated endpoint in fatigue-related conditions. The 48-meter differential improvement between Ampligen and placebo groups in severe cases (p<0.02) exceeds the minimal clinically important difference typically considered meaningful in similar conditions.
The trial's results carry heightened significance in light of the NIH RECOVER initiative's findings of a 500% increase in ME/CFS prevalence post-pandemic. This dramatic surge represents a substantial market opportunity, potentially transforming Ampligen from a niche treatment into a mainstream therapeutic option. The company's strategic decision to focus future trials on moderate-to-severe cases demonstrates astute clinical development planning, as this population showed the most robust response and represents the highest unmet medical need.
The statistical significance (p<0.02) in the severe subgroup analysis suggests a real treatment effect, though it's important to note this was likely a post-hoc analysis. The company's transparent approach in identifying the optimal patient population for future trials indicates confidence in the drug's mechanism of action and increases the probability of success in subsequent studies.
The market implications of AIM's clinical results are substantial, particularly considering the unprecedented expansion of the target patient population. With ME/CFS cases increasing five-fold post-pandemic, we're looking at a dramatic market expansion from what was historically a relatively niche indication. The focus on moderate-to-severe cases is particularly strategic from a commercial perspective, as these patients typically have treatment options and higher healthcare utilization.
The positive efficacy signal in severe cases (baseline 6MWT <205 meters) provides a clear path for market positioning and could support premium pricing strategies. This targeted approach to patient selection could significantly enhance the drug's value proposition to payers, as treating the most severely affected patients typically offers the best opportunity for demonstrable cost-benefit outcomes.
The timing of these results is optimal, coinciding with growing recognition of Long COVID and ME/CFS as serious public health concerns. This alignment of clinical validation with market need could accelerate both regulatory pathways and market adoption, potentially positioning AIM for significant market penetration in what has become a substantially larger therapeutic space.
OCALA, Fla., Jan. 23, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the final Clinical Study Results for the “Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions” (“AMP-518”) was posted yesterday to ClinicalTrials.gov (See: NCT05592418).
CEO Thomas K. Equels stated: “The results of AMP-518 support AIM’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue. Our analysis of the final Clinical Study Results has helped us to identify a likely subject population that would experience the greatest benefit from Ampligen in AIM’s planned follow-up clinical trial. The AMP-518 data also comes on the heels of a new analysis of data that was generated through the National Institutes of Health RECOVER initiative, demonstrating a clear link between Long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. The report found that the prevalence of patients who met the 2015 Institute of Medicine ME/CFS clinical diagnostic criteria is five times higher than before the start of the COVID-19 pandemic. This means there has been a considerable increase in the number of patients that could be classified as having ME/CFS resulting from their COVID-19 infection. Hundreds of thousands of people have suffered from the painful and debilitating disorder of ME/CFS over the decades. With the growing reality of COVID-induced ME/CFS, it is now more important than ever that companies such as AIM and the public sector work together to develop meaningful therapies. We must take action to solve this unmet need, and not let another generation be lost to the ravages of ME/CFS.”
AIM had previously reported positive topline results from its AMP-518 Phase 2 clinical trial. In further analyzing the results of AMP-518, AIM determined that, in this study, Ampligen-treated 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 whose COVID-related fatigue or ME/CFS symptoms can be categorized as moderate or worse.
Read AIM’s January 22, 2025 press release: “AIM ImmunoTech Highlights New Article Finding Links Between COVID-19 and ME/CFS”
Read “Incidence and Prevalence of Post-COVID-19 Myalgic Encephalomyelitis: A Report from the Observational RECOVER-Adult Study” in the Journal of General Internal Medicine.
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 Long COVID or ME/CFS. 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.
FAQ
What were the key results of AIM's AMP-518 Phase 2 trial for Ampligen?
How much more prevalent is ME/CFS after COVID-19 according to the NIH RECOVER study?
What is AIM's next step following the AMP-518 trial results?
What was the primary measurement method used in AIM's AMP-518 trial?
Which patient group showed the most promising results in AIM's Ampligen trial?
