AIM ImmunoTech Submits Pre-IND Application to the FDA for Phase 2 Clinical Studies of Ampligen as a Potential Early-Onset Therapeutic for COVID-19
AIM Has Reached Multiple Major Milestones Demonstrating Strong Progress in Developing its COVID-19 Portfolio
OCALA, Fla., Sept. 28, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that is has submitted a Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for two separate Phase 2 clinical studies to study the potential of Ampligen as both an infusion and an intranasal therapy for early-onset COVID-19, the disease caused by SARS-CoV-2.
The two clinical trials will be Phase 2, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of Ampligen as an:
Intravenous therapy - 200 mg of Ampligen or placebo, with five doses over a treatment period of 17 days; and an
Intranasal therapy - 1,250 μg spray (625 μg per nostril), with seven doses over a treatment period of 15 days.
In addition to studying efficacy and safety, the new Phase 2 protocols include exploratory endpoints that the company believes could support its recently filed provisional patent application.
AIM CEO Thomas K. Equels stated: "With Ampligen's recently established intranasal safety profile, and the preliminary results from these trials, we may be able to show that Ampligen not only has an early-onset therapeutic effect against a broad spectrum of respiratory viruses, but also may provide a boost to post-infection immunity that will confer cross-protection against viral variants. We believe the clearly defined exploratory endpoints for the upcoming trials will substantially validate the significant potential of Ampligen. Moreover, as the principal architect of AIM's developing portfolio of COVID-19-related inventions, I personally believe our most recent provisional patent application for Ampligen, as an early-onset intranasal therapy, stands out as an extremely important development in the progression of our patent portfolio."
AIM believes that it is critical to test the potential of Ampligen as both an intravenous and an intranasal therapy for early-onset COVID-19, as there is science to support the potential of both approaches.
Ampligen has demonstrated clear activity in prior SARS-CoV-1 virus animal experiments. With a SARS-CoV-1 virus mouse models, Ampligen demonstrated 100% protective survival benefit compared to 100% mortality in a saline control group. Ampligen also reduced SARS-CoV-1 lung titers to below the level of detection.
Based on the SARS-CoV-1 data, AIM pursued a successful invitro testing model at the Institute for Antiviral Research at Utah State University, with results showing that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.
Additionally, in June 2021 AIM announced that all subjects have completed treatment in a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level.
Intranasal Ampligen conferred a boost to homologous reactivity when used as an influenza vaccine adjuvant. Further, the TLR-3 agonist - when administered intranasally - induced epitope spreading and clear cross-reactivity against heterologous viral variants. (See: Overton 2014, Ichinohe 2007, Ichinohe 2010)
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 disease caused by the SARS-CoV-2 virus.
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" 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. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. No assurances can be given as to whether any studies will be successful or yield favorable data. Studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of respiratory viruses, including SARS-CoV-2, as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.