AIM ImmunoTech Highlights New Article Finding Links Between COVID-19 and ME/CFS
AIM ImmunoTech (NYSE American: AIM) comments on a new study published in the Journal of General Internal Medicine that reveals significant links between COVID-19 and ME/CFS. The study found that among COVID-19 infected participants, ME/CFS incidence was 15 times higher than pre-pandemic rates, with 4.5% prevalence among infected participants.
The company's drug Ampligen showed promising results in their AMP-518 clinical program for Post-COVID fatigue treatment. Patients with baseline Six-Minute Walk Test less than 205 meters showed significant improvement, with a mean increase of 139 meters compared to 91 meters in the placebo group (p<0.02).
Earlier data published in PLOS One demonstrated Ampligen's effectiveness in treating ME/CFS when administered early (2-8 years of symptom onset), with 51.2% of treated subjects showing at least 25% improvement in exercise duration (p=0.003).
AIM ImmunoTech (NYSE American: AIM) commenta un nuovo studio pubblicato nel Journal of General Internal Medicine che rivela collegamenti significativi tra COVID-19 e ME/CFS. Lo studio ha trovato che tra i partecipanti infetti da COVID-19, l'incidenza di ME/CFS era 15 volte superiore rispetto ai tassi pre-pandemia, con una prevalenza del 4,5% tra i partecipanti infetti.
Il farmaco dell'azienda, Ampligen, ha mostrato risultati promettenti nel programma clinico AMP-518 per il trattamento della fatica post-COVID. I pazienti con un punteggio alla Six-Minute Walk Test di base inferiore a 205 metri hanno mostrato un miglioramento significativo, con un aumento medio di 139 metri rispetto ai 91 metri del gruppo placebo (p<0.02).
Data precedenti pubblicate in PLOS One hanno dimostrato l'efficacia di Ampligen nel trattare ME/CFS quando somministrato precocemente (2-8 anni dall'insorgenza dei sintomi), con il 51,2% dei soggetti trattati che ha mostrato un miglioramento di almeno il 25% nella durata dell'esercizio (p=0.003).
AIM ImmunoTech (NYSE American: AIM) comenta sobre un nuevo estudio publicado en el Journal of General Internal Medicine que revela vínculos significativos entre COVID-19 y ME/CFS. El estudio encontró que entre los participantes infectados por COVID-19, la incidencia de ME/CFS era 15 veces mayor que las tasas previas a la pandemia, con una prevalencia del 4.5% entre los participantes infectados.
El medicamento de la compañía, Ampligen, mostró resultados prometedores en su programa clínico AMP-518 para el tratamiento de la fatiga post-COVID. Los pacientes con una prueba de caminata de seis minutos de base inferior a 205 metros mostraron una mejora significativa, con un aumento medio de 139 metros en comparación con 91 metros en el grupo placebo (p<0.02).
Datos anteriores publicados en PLOS One demostraron la efectividad de Ampligen en el tratamiento de ME/CFS cuando se administra de manera temprana (2-8 años después del inicio de los síntomas), con un 51.2% de los sujetos tratados mostrando al menos un 25% de mejora en la duración del ejercicio (p=0.003).
AIM ImmunoTech (NYSE American: AIM)은 일반 내과 저널에 발표된 새로운 연구에 대해 언급하며, COVID-19와 ME/CFS 사이의 중요한 연관성을 보여줍니다. 연구에 따르면 COVID-19에 감염된 참가자 중 ME/CFS 발생률은 팬데믹 이전 비율보다 15배 높았다고 하며, 감염된 참가자들 중 4.5%의 유병률이 확인되었습니다.
회사의 약물 Ampligen은 포스트 COVID 피로 치료를 위한 AMP-518 임상 프로그램에서 유망한 결과를 보였습니다. 기초 6분 걷기 테스트에서 205미터 미만인 환자들은 의미 있는 개선을 보였으며, 평균 139미터의 증가를 보였고, 이는 위약 그룹의 91미터에 비해 (p<0.02)였습니다.
PLOS One에 발표된 이전 데이터에 따르면, 증상이 시작된 후 2-8년 이내에 조기 투여된 Ampligen의 효과가 ME/CFS 치료에 있음을 보여주었으며, 치료받은 피험자의 51.2%가 운동 지속 시간에서 최소 25%의 개선을 보였습니다 (p=0.003).
AIM ImmunoTech (NYSE American: AIM) commente une nouvelle étude publiée dans le Journal of General Internal Medicine qui révèle des liens significatifs entre COVID-19 et ME/CFS. L'étude a révélé qu'entre les participants infectés par le COVID-19, l'incidence de ME/CFS était 15 fois plus élevée que les taux pré-pandémiques, avec une prévalence de 4,5 % parmi les participants infectés.
Le médicament de l'entreprise, Ampligen, a montré des résultats prometteurs dans leur programme clinique AMP-518 pour le traitement de la fatigue post-COVID. Les patients présentant un Test de Marche de Six Minutes de base inférieur à 205 mètres ont montré une amélioration significative, avec une augmentation moyenne de 139 mètres par rapport à 91 mètres dans le groupe placebo (p<0,02).
Des données antérieures publiées dans PLOS One ont démontré l'efficacité d'Ampligen dans le traitement de ME/CFS lorsqu'il est administré tôt (2-8 ans après le début des symptômes), 51,2 % des sujets traités montrant au moins 25 % d'amélioration de la durée de l'exercice (p=0,003).
AIM ImmunoTech (NYSE American: AIM) kommentiert eine neue Studie, die im Journal of General Internal Medicine veröffentlicht wurde und signifikante Zusammenhänge zwischen COVID-19 und ME/CFS aufzeigt. Die Studie ergab, dass die Inzidenz von ME/CFS bei COVID-19-infizierten Teilnehmern 15 Mal höher war als vor der Pandemie, mit einer Prävalenz von 4,5% unter den infizierten Teilnehmern.
Das Medikament des Unternehmens, Ampligen, zeigte vielversprechende Ergebnisse im klinischen Programm AMP-518 zur Behandlung von post-COVID-Fatigue. Patienten, die im Basistest der Sechs-Minuten-Gehtest weniger als 205 Meter erreicht hatten, zeigten eine signifikante Verbesserung mit einem durchschnittlichen Anstieg von 139 Metern im Vergleich zu 91 Metern in der Placebo-Gruppe (p<0.02).
Frühere Daten, die in PLOS One veröffentlicht wurden, demonstrierten die Wirksamkeit von Ampligen bei der Behandlung von ME/CFS, wenn es früh (2-8 Jahre nach Beginn der Symptome) verabreicht wurde, wobei 51,2% der behandelten Probanden mindestens 25% Verbesserung in der Dauer der körperlichen Betätigung zeigten (p=0.003).
- Ampligen showed significant improvement in Long COVID patients' walking ability (139m vs 91m placebo, p<0.02)
- 51.2% of early-stage ME/CFS patients showed 25% improvement in exercise duration with Ampligen (p=0.003)
- Strong clinical evidence linking Long COVID and ME/CFS supports company's strategic focus
- Treatment effectiveness to early-stage ME/CFS patients (2-8 years window)
- Clinical benefits restricted to patients with severe baseline conditions (walking <205 meters)
Insights
The latest research findings present a compelling case for AIM ImmunoTech's strategic positioning in the ME/CFS and Long COVID therapeutic space. The study revealing a 15-fold increase in ME/CFS incidence post-COVID infection effectively expands the potential market for Ampligen significantly.
The drug's demonstrated efficacy is particularly noteworthy in two aspects: First, the Six-Minute Walk Test results showing a 139-meter improvement in severe cases (p<0.02) suggests strong therapeutic potential for the most impacted patients. Second, the early-intervention data indicating 51.2% of patients achieving significant exercise improvements within the 2-8 year treatment window provides a clear therapeutic strategy.
From a market perspective, several factors strengthen AIM's position: 1) The lack of approved treatments for both ME/CFS and Long COVID creates a significant opportunity 2) The documented overlap between these conditions allows for potential dual indication approval 3) The early-onset therapeutic advantage could establish Ampligen as a first-line treatment.
However, investors should note key considerations: 1) The necessity for larger confirmatory trials 2) The specific timing requirements for optimal efficacy may limit the addressable patient population 3) The potential need for long-term safety data in these chronic conditions.
For a micro-cap company with a market cap of
Recently published article on study findings underscores links between study participants infected with SARS-CoV-2 and the incidence of ME/CFS
The early-onset broad-spectrum antiviral effect of Ampligen has been observed to stimulate strong innate immune response, offering potential therapeutic benefits for people with ME/CFS or Post-COVID chronic fatigue
OCALA, Fla., Jan. 22, 2025 (GLOBE NEWSWIRE) -- 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,
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.
FAQ
What were the key findings of the RECOVER study regarding COVID-19 and ME/CFS mentioned in AIM's announcement?
What were the results of AIM's AMP-518 clinical trial for Ampligen in Long COVID patients?
How effective is Ampligen in treating early-stage ME/CFS according to the PLOS One study?
What is the therapeutic window for Ampligen's effectiveness in ME/CFS patients?
