On Jun. 11, 2020, AIM ImmunoTech announced that it had filed a provisional patent application for, among other discoveries, the use of its experimental drug Ampligen as a potential early-onset therapy for the treatment of COVID-19 induced chronic fatigue, which showed similarities to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Ampligen, approved in Argentina, is late-stage in the experimental development pipeline in the U.S.

While there is ongoing and planned research by the U.S. Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH) and other groups to study chronic fatigue in post-COVID-19 patients, the Company believes Ampligen may play an important role in addressing this multi-faceted disease.

Dr. Charles Lapp of Hunter-Hopkins Center, one of the world’s leading experts in ME/CFS, who is one of the investigators treating CFS patients with Ampligen under an FDA-authorized open-label expanded access treatment protocol, noted, “It is anticipated that COVID-19 will trigger a large number of CFS cases, providing an opportunity for the medical community to learn more about the onset and pathogenesis of CFS. The investigational immune-modulating antiviral drug Ampligen might have a role to play in this scenario.” Although the specific etiology and exact causes of ME/CFS are not known at this time, research suggests there may be multiple variants of the disease with an array of symptoms that often follow severe viral infection. The Institute of Medicine estimates that between 800,000 and 2.5 million U.S. residents live with ME/CFS, and that an estimated three-quarters of these cases were triggered by viral or bacterial infections. Such agents may include the coronavirus, the Epstein-Barr virus, the Ross River virus, and the bacterium, Coxiella burnetii which causes Q fever.