On Nov. 2, 2022, AIM ImmunoTech announced that the U.S. Food and Drug Administration had granted Orphan Drug Designation to Ampligen (rintatolimod) for the treatment of Ebola virus disease. Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system.

Ebola virus disease (EVD) is a rare but severe, deadly disease causing a multitude of symptoms including fever, gastrointestinal issues, aches, and bruising. Previous animal studies yielded positive results utilizing Ampligen in Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. AIM is currently evaluating the safety and effectiveness of intravenous Ampligen to reduce replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients. The Company plans to conduct an intranasal study of Ampligen to potentially enhance and expand natural immunity.

The Orphan Drug Designation program provides Orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the U.S. or meets certain cost recovery provisions. Orphan Drug Designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval.