AIM ImmunoTech announces positive final results from its AMP-518 clinical trial for Ampligen treating post-COVID fatigue.
Quiver AI Summary
AIM ImmunoTech Inc. announced that the final clinical results of its study, "AMP-518," evaluating the efficacy and safety of Ampligen in patients with post-COVID conditions, were posted to ClinicalTrials.gov. CEO Thomas K. Equels emphasized that the findings support Ampligen’s potential as a treatment for moderate-to-severe post-COVID fatigue. The analysis revealed a significant improvement in walking distance among Ampligen-treated subjects with Long COVID compared to a placebo group. This comes alongside new data linking Long COVID to increased rates of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), highlighting a growing population needing effective therapies. AIM intends to focus future trials on patients with moderate or worse symptoms and stresses the importance of collaboration to meet this urgent therapeutic need.
Potential Positives
- The final Clinical Study Results for the study evaluating Ampligen in patients with Post-COVID conditions were successfully posted to ClinicalTrials.gov, signaling transparency and compliance with regulatory standards.
- The study indicates a significant improvement in walking distance for Ampligen-treated patients with Long COVID compared to the placebo group, suggesting therapeutic potential that may influence future clinical trial designs.
- The analysis highlights a growing patient population with COVID-induced Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, emphasizing the unmet medical need that Ampligen could address.
- AIM's CEO expresses a strong commitment to developing meaningful therapies for affected individuals, aligning the company with a critical healthcare need and enhancing its corporate social responsibility profile.
Potential Negatives
- The press release emphasizes that the data does not guarantee future approval of Ampligen as a therapy for Long COVID or ME/CFS, highlighting ongoing uncertainties regarding its efficacy and regulatory outcomes.
FAQ
What are the key results from the AMP-518 clinical study?
The AMP-518 study showed that Ampligen-treated patients with Long COVID had significant improvements in walking distance compared to the placebo group.
How does Ampligen relate to Post-COVID conditions?
AIM ImmunoTech believes Ampligen may serve as a potential therapeutic for individuals suffering from moderate-to-severe Post-COVID fatigue.
What is the link between Long COVID and ME/CFS?
A recent analysis indicated that the prevalence of ME/CFS has increased fivefold since the COVID-19 pandemic began, impacting many survivors.
What is the significance of the 6-Minute Walk Test in the study?
The 6-Minute Walk Test measured improvements in walking distances, indicating potential benefits of Ampligen treatment for Long COVID patients.
How can I find more information about AIM ImmunoTech?
For more information about AIM ImmunoTech and its research, visit aimimmuno.com or connect with the company on social media platforms.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$AIM Insider Trading Activity
$AIM insiders have traded $AIM stock on the open market 10 times in the past 6 months. Of those trades, 9 have been purchases and 1 have been sales.
Here’s a breakdown of recent trading of $AIM stock by insiders over the last 6 months:
- THOMAS K EQUELS (CEO & President) has made 6 purchases buying 212,837 shares for an estimated $44,511 and 0 sales.
- STEWART APPELROUTH has made 3 purchases buying 93,065 shares for an estimated $18,172 and 0 sales.
- WILLIAM M MITCHELL sold 4,580 shares for an estimated $883
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$AIM Hedge Fund Activity
We have seen 13 institutional investors add shares of $AIM stock to their portfolio, and 11 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- CITADEL ADVISORS LLC added 359,740 shares (+367.0%) to their portfolio in Q3 2024, for an estimated $97,129
- ARMISTICE CAPITAL, LLC added 252,000 shares (+6.2%) to their portfolio in Q3 2024, for an estimated $68,040
- TWO SIGMA SECURITIES, LLC removed 125,003 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $33,750
- BRIDGEWAY CAPITAL MANAGEMENT, LLC removed 77,900 shares (-87.6%) from their portfolio in Q3 2024, for an estimated $21,033
- GEODE CAPITAL MANAGEMENT, LLC added 62,989 shares (+15.7%) to their portfolio in Q3 2024, for an estimated $17,007
- XTX TOPCO LTD added 51,371 shares (+353.6%) to their portfolio in Q3 2024, for an estimated $13,870
- VIRTU FINANCIAL LLC added 45,929 shares (+81.7%) to their portfolio in Q3 2024, for an estimated $12,400
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
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.