AIM ImmunoTech Inc. (NYSEAMERICAN:AIM) has announced the receipt of an Institutional Review Board Approval for expansion of the AMP-511 Expanded Access Program clinical study for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). This includes for patients that were previously diagnosed with COVID-19 but have still shown chronic fatigue-like symptoms.
AIM evaluating Ampligen in treating Chronic Fatigue
The company is treating patients in the study with their flagship drug Ampligen. Patients that are often referred to as Post-COVID-19 Chronic Fatigue (PCCF)/ “Long Haulers” due to the persistence of symptoms will receive ampligen treatment alongside the patients with ME/CFS in the Expanded Access program. According to a new study protocol amendment, 20 in 100 participants are likely to be Long Haulers. Currently, the company is readying the IRB-approved protocol for FDA submission.
Charles Lapp, a global ME/CFS expert, stated that COVID-19 can potentially trigger considerable CFS cases, which offers the medical community an opportunity to get more insight on CFS’ onset and pathogenesis. He added that the experimental immune-modulating antiviral drug ampligen could play a vital role in this circumstance.
After the 2003 SARS-COV-1 pandemic, most survivors continued reporting classic chronic like fatigue signs after recovery from acute illness. Around 27% of the survivors meet the chronic fatigue syndrome criteria from the CDC. Interestingly there is now growing evidence that COVID-19 patients could also develop ME/CFS-like symptoms.
Early administration of Ampligen on COVID-19 patients can result in better outcomes
Thomas Equels, the CEO of AIM, stated that millions of COVID-19 cases in the US and a tidal wave of new cases are expected, with those infected showing symptoms similar to chronic fatigue. Equels added that unpublished data from the company shows that ME/CFS patients can respond better to ampligen provided they receive the drug earlier. Therefore early enrolment of “Long Haulers” could potential benefit them while at the same time offering vital information for ME/CFS patients. Recently the company filed an interim utility patent application for the drug as a possible COVID-19-induced ME/CFS therapy.