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AIM ImmunoTech Expands Patent Portfolio with New Netherlands Composition and Methods Patent Covering Ampligen for Use in the Post-COVID Condition of Fatigue

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AIM ImmunoTech (NYSE American: AIM) has secured Patent No. 2,032,813 from the Netherlands Patent Office for its drug Ampligen (rintatolimod) to treat post-COVID fatigue. The patent was granted to CEO Thomas K. Equels and Medical Officer David R. Strayer, who assigned it to the company.

Ampligen, an RNA product candidate designed to modulate the immune system, has shown broad-spectrum antiviral effects through stimulating innate immune response. The company recently reported positive topline results from its Phase 2 study (AMP-518) evaluating Ampligen's efficacy and safety in treating post-COVID fatigue. The drug was generally well-tolerated and showed preliminary evidence of reducing fatigue in subjects with post-COVID conditions.

Based on these results, AIM plans to conduct a follow-up clinical trial focusing on moderate-to-severe post-COVID fatigue patients.

AIM ImmunoTech (NYSE American: AIM) ha ricevuto il Brevetto N. 2.032.813 dall'Ufficio Brevetti dei Paesi Bassi per il suo farmaco Ampligen (rintatolimod) per trattare la fatica post-COVID. Il brevetto è stato assegnato al CEO Thomas K. Equels e al Direttore Medico David R. Strayer, che lo hanno trasferito all'azienda.

Ampligen, un candidato farmacologico basato su RNA progettato per modulare il sistema immunitario, ha mostrato effetti antivirali a ampio spettro stimolando la risposta immunitaria innata. L'azienda ha recentemente riportato risultati positivi dai dati preliminari del suo studio di Fase 2 (AMP-518) che valuta l'efficacia e la sicurezza di Ampligen nel trattamento della fatica post-COVID. Il farmaco è stato generalmente ben tollerato e ha mostrato prove preliminari di riduzione della fatica nei soggetti con condizioni post-COVID.

In base a questi risultati, AIM prevede di condurre uno studio clinico di follow-up focalizzato sui pazienti con fatica post-COVID da moderata a severa.

AIM ImmunoTech (NYSE American: AIM) ha obtenido la Patente N. 2,032,813 de la Oficina de Patentes de los Países Bajos para su medicamento Ampligen (rintatolimod) para tratar la fatiga post-COVID. La patente fue concedida al CEO Thomas K. Equels y al Director Médico David R. Strayer, quienes la asignaron a la empresa.

Ampligen, un candidato a fármaco basado en ARN diseñado para modular el sistema inmunológico, ha mostrado efectos antivirales de amplio espectro al estimular la respuesta inmune innata. La empresa informó recientemente resultados positivos de los resultados preliminares de su estudio de Fase 2 (AMP-518) que evalúa la eficacia y seguridad de Ampligen en el tratamiento de la fatiga post-COVID. El fármaco fue generalmente bien tolerado y mostró evidencia preliminar de reducción de la fatiga en sujetos con condiciones post-COVID.

Con base en estos resultados, AIM planea llevar a cabo un ensayo clínico de seguimiento centrado en pacientes con fatiga post-COVID de moderada a severa.

AIM ImmunoTech (NYSE American: AIM)는 네덜란드 특허청으로부터 Ampligen (rintatolimod)의 특허 번호 2,032,813을 확보하여 포스트 COVID 피로 치료에 사용합니다. 이 특허는 CEO Thomas K. Equels와 의료 책임자 David R. Strayer에게 부여되었으며, 그들은 이를 회사에 양도했습니다.

Ampligen은 면역 체계를 조절하도록 설계된 RNA 기반 약물 후보로, 선천적인 면역 반응을 자극하여 광범위한 항바이러스 효과를 나타냈습니다. 이 회사는 최근 Ampligen의 포스트 COVID 피로 치료에 대한 효능과 안전성을 평가한 2상 연구(AMP-518)에서 긍정적인 초기 결과를 보고했습니다. 이 약물은 일반적으로 잘 견디어냈으며, 포스트 COVID 상태를 가진 피험자들의 피로를 줄인 초기 증거를 보여주었습니다.

이러한 결과를 바탕으로 AIM은 중간에서 심각한 포스트 COVID 피로 환자들을 대상으로 하는 후속 임상 시험을 실시할 계획입니다.

AIM ImmunoTech (NYSE American: AIM) a obtenu le brevet N° 2.032.813 de l'Office des brevets des Pays-Bas pour son médicament Ampligen (rintatolimod) destiné à traiter la fatigue post-COVID. Le brevet a été accordé au PDG Thomas K. Equels et au directeur médical David R. Strayer, qui l'ont cédé à l'entreprise.

Ampligen, un candidat médicament basé sur l'ARN conçu pour moduler le système immunitaire, a montré des effets antiviraux à large spectre en stimulant la réponse immunitaire innée. L'entreprise a récemment rapporté des résultats positifs des premières conclusions de son étude de phase 2 (AMP-518) évaluant l'efficacité et la sécurité d'Ampligen dans le traitement de la fatigue post-COVID. Le médicament a été généralement bien toléré et a montré des preuves préliminaires de réduction de la fatigue chez les sujets ayant des conditions post-COVID.

Sur la base de ces résultats, AIM prévoit de mener un essai clinique de suivi axé sur les patients souffrant de fatigue post-COVID modérée à sévère.

AIM ImmunoTech (NYSE American: AIM) hat das Patent Nr. 2.032.813 vom niederländischen Patentamt für sein Medikament Ampligen (rintatolimod) zur Behandlung von post-COVID-Fatigue gesichert. Das Patent wurde an CEO Thomas K. Equels und Medical Officer David R. Strayer vergeben, die es an das Unternehmen übertragen haben.

Ampligen, ein RNA-Arzneimittelkandidat, der entwickelt wurde, um das Immunsystem zu modulieren, hat durch die Stimulation der angeborenen Immunantwort breite antivirale Wirkungen gezeigt. Das Unternehmen berichtete kürzlich von positiven Ergebnissen aus seiner Phase-2-Studie (AMP-518), die die Wirksamkeit und Sicherheit von Ampligen zur Behandlung von post-COVID-Fatigue bewertet. Das Medikament wurde allgemein gut vertragen und zeigte vorläufige Hinweise darauf, dass es die Fatigue bei Patienten mit post-COVID-Bedingungen verringert.

Basierend auf diesen Ergebnissen plant AIM, eine Follow-up-Studie durchzuführen, die sich auf Patienten mit moderater bis schwerer post-COVID-Fatigue konzentriert.

Positive
  • Secured new Netherlands patent for Ampligen in post-COVID fatigue treatment
  • Positive Phase 2 trial results showing efficacy in reducing post-COVID fatigue
  • Drug demonstrated good tolerability in clinical trials
  • Expanding global intellectual property portfolio with multiple patents
Negative
  • Results are preliminary and require follow-up clinical trials
  • to moderate-to-severe post-COVID fatigue cases

Insights

The Netherlands patent grant for Ampligen in post-COVID fatigue treatment represents a significant intellectual property milestone for AIM ImmunoTech. The positive Phase 2 study results showing Ampligen's safety and preliminary efficacy in treating post-COVID fatigue provide a strong foundation for future development. This positions AIM strategically in the growing post-COVID therapeutics market, where effective treatments are still largely unavailable.

The patent strengthens AIM's competitive position in Europe, particularly given their research collaboration with Erasmus Medical Center. The company's expanding IP portfolio, including patents for cancer immunotherapy combinations and Chronic Fatigue Syndrome treatment, demonstrates a comprehensive approach to protecting their technology across multiple indications.

While this patent expansion enhances AIM's intellectual property value, investors should consider the company's market cap of $13.7M in context. The development of Ampligen for post-COVID fatigue represents a significant market opportunity, given the large patient population affected by long COVID. However, additional clinical trials and regulatory approvals will require substantial capital investment.

The strategic focus on multiple indications, including cancer and chronic fatigue syndrome, provides diversification but also means resources must be spread across various development programs. The positive Phase 2 results could attract potential partnerships or investment interest, which would be important for advancing to later-stage trials.

OCALA, Fla., Dec. 12, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the Netherlands Patent Office (Octrooicentrum Nederland) has granted Patent No. 2,032,813 — a compositions and methods patent — covering Ampligen® (rintatolimod) for use in the treatment of the post-COVID condition of fatigue. The patent inventors, AIM CEO Thomas K. Equels and AIM Medical Officer David R. Strayer, M.D., have assigned the granted patent to the Company.

AIM CEO Thomas K. Equels commented, “Over the course of the past year in particular, we have had great success in expanding our global intellectual property portfolio, with U.S. patents for the combination of Ampligen with immune checkpoint inhibitors for the treatment of challenging cancers, for a novel method for the treatment of Chronic Fatigue Syndrome, and for methods and compositions for treating debilitating endometriosis. We are pleased to continue executing on that initiative and to further broaden AIM’s existing portfolio for the treatment of COVID-19-related illnesses with this new Netherlands patent. Much of our European research is conducted in the Netherlands at the world-renowned Erasmus Medical Center.”

Ampligen is AIM’s RNA product candidate designed to modulate the immune system. Data from in vitro, pre-clinical and clinical experiments suggest that Ampligen has a broad-spectrum early-onset antiviral effect by stimulating a strong innate immune response. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a strong impact on viral replication. Additionally, AIM conducted a Phase 2 study evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the post-COVID condition of fatigue (“AMP-518”) and recently reported positive topline results demonstrating Ampligen to be generally well tolerated and efficacy results offering preliminary evidence that Ampligen may reduce fatigue in subjects with post-COVID conditions. Upon analysis of the complete clinical patient data from the AMP-518 clinical trial, the Company believes Ampligen has the potential to be a therapeutic for people with the moderate-to-severe post-COVID condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial.

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 XLinkedIn, 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 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 is the significance of AIM's new Netherlands patent for Ampligen?

The patent (No. 2,032,813) allows AIM ImmunoTech to use Ampligen for treating post-COVID fatigue in the Netherlands, expanding their intellectual property portfolio and market potential.

What were the results of AIM's Phase 2 trial for Ampligen in post-COVID fatigue?

The Phase 2 trial (AMP-518) showed positive topline results, with Ampligen being generally well-tolerated and demonstrating preliminary evidence of reducing fatigue in post-COVID condition patients.

What is Ampligen's mechanism of action according to AIM's research?

Ampligen is an RNA product that modulates the immune system by stimulating a strong innate immune response, showing broad-spectrum early-onset antiviral effects and impact on viral replication in SARS-CoV-2.

What are AIM's future plans for Ampligen in post-COVID treatment?

AIM plans to conduct a follow-up clinical trial focusing specifically on patients with moderate-to-severe post-COVID condition of fatigue.

AIM ImmunoTech Inc.

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