Benzinga | Sep 27, 2021 09:21AM EDT

AIM ImmunoTech Files Provisional Patent Application For Ampligen As Early-Onset Intranasal Therapy That May Also Confer Enhanced Immunity To A Wide Range Of Respiratory Viruses

AIM ImmunoTech Inc. (NYSE:AIM) today announced the filing of a provisional patent application for Ampligen as a potential early-onset intranasal therapy designed to enhance and expand infection-induced immunity, epitope spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses, such as influenza, Rhinoviruses and SARS-CoV-2, which causes the disease COVID-19.



The new filing concerns the early-stage administration of Ampligen following active viral replication after a respiratory virus has entered a person's nasal passages. AIM believes that Ampligen -- which is thought to be a powerful immune system modulator -- can help the body respond to such an infection by first activating the innate immune system to blunt viral replication, and then, as a second important step, inducing an enhanced cross-protective immune response or a broad-based immune response, both to the virus and potential variants of the virus.

Applications for clinical trial authorization, which the Company plans to file in the near future, are expected to include intranasal therapeutic effect as a primary endpoint, but also exploratory endpoints to gather data supporting the Ampligen-enhanced immunity.

"We have designed upcoming clinical trials with exploratory endpoints that we believe will provide data supporting this novel concept and further validate Ampligen's potential as an early-onset intranasal therapy," said AIM CEO Thomas K. Equels. "When vaccines are not available, or where no vaccine has been developed, this therapy would use the power of the virus against the virus. From a public health perspective, this may be a critical new concept, especially for future novel viral outbreaks where no vaccine has been developed. This approach builds on the strong existing data demonstrating Ampligen's broad antiviral activity against a range of respiratory viruses, combined with the encouraging results from our recently completed Phase 1 clinical trial to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy, which determined that the highest-dosage and the every other day frequency of administration of intranasal Ampligen was generally well-tolerated."

AIM's COVID-19 patent portfolio also includes:

* A provisional patent application for Ampligen as both an intranasal and an intravenous therapy for what AIM describes as Post-COVID-19 Cognitive Dysfunction (PCCD). Multiple provisional patient applications for Ampligen as a COVID-19 therapy and as an intranasal COVID-19 vaccine adjuvant.