AIM ImmunoTech Inc (NYSEAMERICAN:AIM) announced it has signed a contract to sponsor a Phase 2a Human Challenge Trial (HCT) to test the company’s Ampligen drug as a potential intranasal antiviral therapy to treat Rhinovirus hRV (common cold virus) and Influenza.
The company said a successful Phase 2a study could 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 coronavirus (COVID-19).
“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,” AIM ImmunoTech CEO Thomas Equels said in a statement.
READ: AIM ImmunoTech completes Phase 1 clinical study of its flagship drug Ampligen
“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,” Equels added.
“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.”
AIM noted the HCT will allow the company 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.
The Phase 2a trial is expected to begin in the fourth quarter of 2021 and will be conducted by hVIVO, a subsidiary of Open Orphan PLC.
Ampligen targets and amplifies the natural immune system pathways that fight viruses, meaning the drug 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, the company said.
The Phase 2a study will test this proposition in humans.
AIM 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.
Contact Sean at sean@proactiveinvestors.com