Benzinga | Jul 9, 2021 07:26AM EDT

AIM ImmunoTech Reports Phase 2a Human Challenge Trial To Test Its Drug Ampligen As Intranasal Antiviral Prophylactic Therapy

AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has signed a contract to sponsor a Phase 2a Human Challenge Trial (HCT) to test the company's drug Ampligen as a potential intranasal antiviral therapy using a human Rhinovirus hRV (common cold virus) and Influenza.

This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organization and world leader in vaccine and antiviral testing using human challenge clinical trials. The trial is expected to commence in Q4 2021.

A successful Phase 2a study could also establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies, as well as known viruses such as SARS-CoV-2, which causes COVID-19.

In an HCT, subjects are intentionally exposed to particular diseases to test how the diseases will respond to potential therapeutics. An HCT will allow AIM to expedite the development process for Ampligen by ensuring high infection rates for subjects who receive the drug, therefore also ensuring large data sets with potentially statistically significant results.

This Phase 2a study will come in the wake of AIM's recent announcement that all subjects have completed treatment in the company's 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 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. A final study report is expect in the third quarter of 2021.

Unlike other drugs tailored to combat specific diseases, Ampligen targets and amplifies the natural immune system pathways that fight viruses, meaning that Ampligen delivered via an intranasal device could be an effective preventive therapy for people who may be exposed to, or have recently been exposed to, a respiratory virus such as influenza, or even common coronaviruses and rhinoviruses (like the common cold). Success against these common viruses could also indicate that an Ampligen prophylaxis could help blunt the spread of infection from lethal coronaviruses, as well as other serious viruses. This Phase 2a study will test this proposition in humans.

AIM CEO Thomas K. Equels, commented: "It is our belief that Ampligen's mechanism of action regarding the human innate immune system gives Ampligen broad-spectrum capabilities as an antiviral prophylaxis and therapeutic. The ability to do a Human Challenge Trial using hRV and Influenza allows us to test in humans Ampligen's potential role as a powerful prophylaxis and therapeutic for a wide range of respiratory viruses. It is our belief that if it works in these two viruses, then it will have the potential to have a similar impact in other respiratory viruses."

Cathal Friel, Executive Chairman of Open Orphan, stated: "We are delighted to commence work with AIM ImmunoTech, a leading immuno-pharma company, to test their product and to demonstrate our expertise in testing vaccines and antivirals using our world-leading portfolio of human challenge models. While the pandemic has undoubtedly inflicted a lot of loss and suffering globally, it has also taught us a valuable lesson in pandemic preparedness. It is my belief therefore that the infectious disease market has been utterly transformed and is going to grow exponentially in the years ahead. Challenge studies are a key weapon in the arsenal against infectious diseases as they can bring effective treatments and vaccines to the market both quicker and faster than they could otherwise."

An Ampligen prophylaxis could potentially benefit vulnerable populations who are at increased risk of transmission due to their environments, such as hospital workers; people on cruise, cargo or military ships; people on commercial airplanes; and service personnel in close quarters on military installations.