Today, AIM ImmunoTech, 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, provided an update on its ongoing efforts to develop an effective therapeutic for Long Covid with its investigational drug, Ampligen.
Ampligen has been studied in clinical trials since the late 1980s, and although it has been endorsed by countries outside the USA specifically for treating people with ME/CFS, it does not have FDA approval.
Long Covid presents as a wide range of symptoms, and approximately one-half of these overlap with symptoms seen in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The application of Ampligen for both diseases is yet another example of how ME/CFS research can benefit people with ME/CFS and Long Covid, and why the study of both is crucial to each community.
A Phase 3 prospective, double-blind, randomized, placebo-controlled trial of Ampligen in ME/CFS (AMP-516) produced improvement in exercise tolerance. An analysis of a subset of patients in that trial with early onset of symptoms showed a statistically significant 51.2% positive response.
In an amendment to its ongoing, FDA-authorized AMP-511 expanded access program (EAP), AIM enrolled four Long Covid patients with new-onset ME/CFS following acute COVID-19. Following at least 12 weeks of Ampligen treatment, each of these four patients indicated they had experienced a reduction in fatigue, as measured via Patient-Reported Outcomes questionnaires. Analysis of the data suggested that the decrease in fatigue compared to baseline was statistically significant, despite the small number of patients.
Based in part on these early positive data, AIM is working toward filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a Phase 2 study of Ampligen for the treatment of Long Covid. The newly planned IND is for 12 weeks of therapy.
In the press release, Solve M.E. President and CEO Oved Amitay remarked on the great interest this study generated because drugs that combat viruses, as well as affect the immune system, could provide a significant benefit to people with post-infection diseases. He underscored that the FDA must work with drug developers and patient advocates to enable the rapid initiation of these important studies on this and other promising treatments.
Read the AIM ImmunoTech press release here.
This week at our May 19 conference “Long Covid: Research, Policy and Economic Impact,” Ampligen CEO Thomas Equels, M.S., J.D., will be a presenter in a panel on Industry-Specific Implications.
Register to attend the conference virtually here.
Special thanks to our event sponsor Responsum Health, a customized, uniquely individualized chronic disease patient platform, for providing streaming services for this event.