AIM ImmunoTech Announces European Patent Office Grants Patent Covering Ampligen® (Rintatolimod) for Use in the Treatment of the Post-COVID Condition of Fatigue

Rhea-AI Summary

AIM (NYSE American: AIM) announced on Nov 3, 2025 that the European Patent Office granted European Patent No. 4,096,675 for "Compositions for Treating LONG COVID," covering compositions of AIM’s dsRNAs including Ampligen (rintatolimod) for use in treating Long COVID.

The release notes prior in vitro, preclinical and clinical evidence, cites decreased SARS‑CoV‑1 replication and >90% structural homology with SARS‑CoV‑2, and references positive topline results from the Phase 2 AMP‑518 study reporting Ampligen was generally well tolerated with efficacy signals for reducing post‑COVID fatigue.

Positive

• European patent granted (No. 4,096,675) for Ampligen in Long COVID
• Phase 2 AMP-518 topline reported positive tolerability and efficacy signals
• Preclinical antiviral data showing decreased SARS‑CoV‑1 replication cited

Negative

• AMP-518 disclosed only as positive topline without detailed efficacy metrics
• No regulatory approvals or Phase 3/registration data for Long COVID are reported

Insights

IP & Regulatory Strategist

European patent grant expands IP cover on Ampligen for Long COVID and supports regulatory positioning in Europe.

AIM ImmunoTechAmpligen® (rintatolimod) for use in treating Long COVID, which creates a legally enforceable composition-of-matter claim in Europe and should reduce generic entry risk within covered jurisdictions.

The value depends on claim breadth, remaining patent term and national validations; enforcement and scope will determine commercial leverage and partnership potential. Watch for national patent validations, oppositions, or scope-limiting decisions over the next 24 months.

Clinical Development & Commercial Advisor

Patent plus reported positive Phase 2 topline results together support commercial development optionality for Ampligen in Long COVID.

The notice references a Phase 2 study (AMP-518) with "positive topline results" and that Ampligen was "generally well tolerated" with evidence of reduced fatigue, which, if confirmed in full analysis, supports further development in a clinically unmet condition.

Key dependencies include the final AMP-518 dataset, statistical significance details, and confirmatory trials; monitor the complete clinical data release and any planned Phase 3 pathway over the next 6–18 months.

OCALA, Fla., Nov. 03, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the European Patent Office has officially granted AIM’s European Patent No. 4,096,675, titled “Compositions for Treating LONG COVID,” covering compositions of matter of AIM’s proprietary dsRNAs including, for example, Ampligen^® (rintatolimod) for use in the treatment of Long COVID.

“While AIM’s immediate and primary focus is to build upon the continued positive results from our late-stage pancreatic cancer clinical program, this new European patent in Long COVID strengthens our intellectual property portfolio while providing additional validation of our belief in Ampligen’s potential as a broad-spectrum immunotherapy,” commented AIM CEO Thomas K. Equels.

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 Ampligen experiments in SARS-CoV-1 showing a significant decrease in viral replication. Since the viral genome of SARS-CoV-1 is highly homologous (>90%) to SARS-CoV-2 structural proteins, this indicates that Ampligen may have similar antiviral activity in Long COVID. Additionally, AIM conducted a Phase 2 study (“AMP-518”) evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the post-COVID condition of fatigue (i.e., Long COVID) and reported positive topline results demonstrating Ampligen to be generally well tolerated and efficacy results offering evidence that Ampligen may reduce fatigue in subjects with post-COVID conditions such as Long COVID. Upon final analysis of the clinical patient data from the AMP-518 clinical trial, the Company believes Ampligen has the potential to be a therapeutic for people with moderate-to-severe Long COVID.

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 any indication. 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.

Investor Contact:

JTC Team, LLC
Jenene Thomas
908.824.0775
AIM@jtcir.com

FAQ

What does the Nov 3, 2025 European patent (No. 4,096,675) mean for AIM (AIM) and Ampligen?

The patent covers compositions including Ampligen for treating Long COVID in Europe, strengthening AIM’s intellectual property position.

What were the AMP-518 Phase 2 topline results announced by AIM (AIM)?

AIM reported AMP-518 topline as generally well tolerated with efficacy signals suggesting reduced fatigue in Long COVID subjects; detailed metrics were not released.

Does the new European patent guarantee Ampligen approval for Long COVID in Europe?

No; a patent protects intellectual property but does not replace required regulatory approvals or Phase 3 data for marketing authorization.

How does AIM link Ampligen’s antiviral activity to Long COVID treatment?

AIM cites decreased replication in SARS‑CoV‑1 studies and >90% structural homology to SARS‑CoV‑2 as a rationale for potential similar antiviral activity in Long COVID.

Is there a published full analysis of AMP-518 for investors to review?

The company referenced a final analysis but the release provides only topline statements and no full dataset or peer‑reviewed publication.

Could the patent affect AIM’s commercial strategy for Ampligen in Long COVID?

The patent may support exclusivity and licensing options in Europe, but commercial impact depends on regulatory results, further trials, and commercialization agreements.