AIM ImmunoTech Announces Publication of Final Clinical Study Results for AMP-518 Clinical Trial on Ampligen as a Therapeutic for Post-COVID Conditions
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.
AIM ImmunoTech (NYSE American: AIM) ha pubblicato i risultati finali dello studio clinico del suo trial di Fase 2 AMP-518 che valuta Ampligen come trattamento per le condizioni post-COVID. Lo studio ha mostrato risultati promettenti, in particolare per i pazienti con affaticamento post-COVID di media-severa intensità.
I risultati chiave hanno rivelato che i pazienti trattati con Ampligen affetti da Long COVID hanno dimostrato una maggiore capacità di camminare rispetto ai gruppi placebo. In particolare, i pazienti con un Test di Cammino di Sei Minuti (6MWT) iniziale inferiore a 205 metri hanno mostrato un miglioramento significativo, raggiungendo un incremento medio di 139 metri contro 91 metri nel gruppo placebo (p <0.02).
L'azienda ha sottolineato i recenti dati dell'iniziativa NIH RECOVER che mostrano come la prevalenza di ME/CFS (Sindrome da Fatica Cronica/Mialgica Encefalomielite) sia ora cinque volte più alta rispetto ai livelli pre-pandemici a causa delle infezioni da COVID-19. Basandosi su questi risultati, AIM prevede di condurre uno studio clinico di follow-up concentrato su pazienti con affaticamento post-COVID di media o peggiore intensità o sintomi di ME/CFS.
AIM ImmunoTech (NYSE American: AIM) ha publicado los resultados finales del estudio clínico de su ensayo de Fase 2 AMP-518 que evalúa Ampligen como tratamiento para las condiciones post-COVID. El estudio mostró resultados prometedores, especialmente para los pacientes con fatiga post-COVID moderada a severa.
Los hallazgos clave revelaron que los pacientes tratados con Ampligen que padecían Long COVID demostraron una mejor capacidad para caminar en comparación con los grupos placebo. Específicamente, los pacientes con una prueba de caminata de seis minutos (6MWT) inicial inferior a 205 metros mostraron una mejora significativa, logrando un aumento medio de 139 metros frente a 91 metros en el grupo placebo (p <0.02).
La empresa destacó datos recientes de la iniciativa RECOVER de los NIH que muestran que la prevalencia de ME/CFS (Síndrome de Fatiga Crónica/Mialgia Encefálica) ahora es cinco veces mayor que los niveles prepandémicos debido a infecciones por COVID-19. Basándose en estos resultados, AIM planea realizar un ensayo clínico de seguimiento centrado en pacientes con fatiga relacionada con COVID moderada o grave o síntomas de ME/CFS.
AIM ImmunoTech (NYSE American: AIM)은 Post-COVID 상태에 대한 치료제로서 Ampligen을 평가하는 AMP-518 2상 시험의 최종 임상 연구 결과를 발표했습니다. 연구 결과는 특히 중간-심한 Post-COVID 피로를 겪는 환자들에게 유망한 결과를 보여주었습니다.
주요 발견은 Long COVID 환자들 중 Ampligen으로 치료받은 환자들이 위약 그룹에 비해 걷기 능력이 향상되었음을 나타냈습니다. 특히, 기준선 6분 걷기 테스트(6MWT)에서 205미터 미만인 환자들은 유의미한 개선을 보여주었으며, 평균 139미터 증가를 달성해 위약 그룹의 91미터와 비교되었습니다 (p <0.02).
회사는 최근 NIH RECOVER Initiative 데이터에서 ME/CFS (근육통성 뇌염/만성 피로 증후군)의 유병률이 COVID-19 감염으로 인해 팬데믹 이전 수치의 5배에 달한다고 강조했습니다. 이 결과를 바탕으로 AIM은 중간 또는 그보다 더 심한 COVID 관련 피로 또는 ME/CFS 증상을 가진 환자들에 초점을 맞춘 후속 임상 시험을 실시할 계획입니다.
AIM ImmunoTech (NYSE American: AIM) a publié les résultats finaux de l'étude clinique de son essai de phase 2 AMP-518 évaluant Ampligen comme traitement pour les conditions post-COVID. L'étude a montré des résultats prometteurs, en particulier pour les patients souffrant de fatigue post-COVID modérée à sévère.
Les résultats clés ont révélé que les patients traités avec Ampligen et atteints de Long COVID ont montré une capacité de marche améliorée comparativement aux groupes placebo. En particulier, les patients avec un Test de Marche de Six Minutes (6MWT) de départ inférieur à 205 mètres ont montré une amélioration significative, atteignant une augmentation moyenne de 139 mètres contre 91 mètres dans le groupe placebo (p <0.02).
L'entreprise a souligné des données récentes de l'initiative NIH RECOVER montrant que la prévalence de ME/CFS (Encéphalomyélite Myalgique/Syndrome de Fatigue Chronique) est désormais cinq fois plus élevée qu'avant la pandémie en raison des infections par le COVID-19. Sur la base de ces résultats, AIM prévoit de réaliser un essai clinique de suivi axé sur des patients souffrant de fatigue liée au COVID de degré modéré ou supérieur ou de symptômes de ME/CFS.
AIM ImmunoTech (NYSE American: AIM) hat die endgültigen klinischen Studienergebnisse für seine AMP-518 Phase 2 Studie veröffentlicht, in der Ampligen als Behandlung für Post-COVID-Bedingungen bewertet wurde. Die Studie zeigte vielversprechende Ergebnisse, insbesondere für Patienten mit moderater bis schwerer Post-COVID-Müdigkeit.
Wesentliche Erkenntnisse zeigten, dass Patienten, die mit Ampligen behandelt wurden und Long COVID hatten, eine verbesserte Gehfähigkeit im Vergleich zu den Placebo-Gruppen aufwiesen. Insbesondere Patienten mit einem Ausgangswert im Sechs-Minuten-Gehtest (6MWT) von weniger als 205 Metern zeigten eine signifikante Verbesserung und erreichten einen durchschnittlichen Anstieg von 139 Metern im Vergleich zu 91 Metern in der Placebo-Gruppe (p <0.02).
Das Unternehmen hob aktuelle Daten der NIH RECOVER-Initiative hervor, die zeigen, dass die Prävalenz von ME/CFS (Myalgische Enzephalomyelitis/Chronisches Fatigue-Syndrom) jetzt fünfmal höher ist als die Prävalenz vor der Pandemie aufgrund von COVID-19-Infektionen. Basierend auf diesen Ergebnissen plant AIM, eine Nachfolgestudie durchzuführen, die sich auf Patienten mit moderater oder schwerer COVID-assoziierter Müdigkeit oder ME/CFS-Symptomen konzentriert.
- 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
- 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
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