Breaking News: FDA clears Ampligen to start a clinical trial in Long Covid

A decade after the U.S. Food and Drug Administration (FDA) did not approve Ampligen (rintatolimod) for the treatment of ME/CFS, this antiviral and immuno-modulator drug is getting a rare second chance.

Ampligen’s developer AIM ImmunoTech, a biotech company focused on the research and development of therapeutics, announced today that the FDA has given a green light to their Investigational New Drug (IND) application for a Phase 2 study of Ampligen for the treatment of Post-Covid conditions (Long Covid). The study will focus on the key symptom of fatigue, as well as cognitive dysfunction (“brain fog”) and sleep disturbance.

The opportunity to resurrect the study of Ampligen would likely not have existed without Long Covid. Building on decades of advocacy from the ME/CFS community, Long Covid successfully reopened the opportunity to bring this long-awaited therapy into use in the United States. The initiation of this formal clinical study is good news for the ME/CFS community.

Should the trial yield promising results, it would open the possibility for an accelerated development and approval process, including potentially an Emergency Use Authorization (EUA) from the FDA, as was the case for treatments of the acute phase of COVID-19. The results from this study may emerge as soon as next year.

Ampligen affects the underlying mechanism of diseases such as Long Covid and ME/CFS, directly addressing shared hallmark symptoms — fatigue, brain fog, and post-exertional malaise (PEM). 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.

“To address the needs of Long Covid patients, it is critical that we apply existing knowledge, such as studies done previously in ME/CFS,” said Solve M.E. President and CEO Oved Amitay. “This study is an important step in addressing the needs of all individuals who face debilitating post-infection symptoms, including those with ME/CFS.”

Ampligen has been studied in clinical trials since the late 1980s. For years, Solve has strongly advocated for the approval of Ampligen for use in treating ME/CFS patients and more recently provided expert input and the patients’ perspective on AIM’s Ampligen protocol.

In January, we hosted leaders from AIM ImmunoTech to discuss their plans for clinical studies of Ampligen, in ME/CFS and Long Covid. Watch the presentation and hear insights from real-world use of Ampligen to treat patients here.

Solve is committed to enabling the evidence-based development of safe and effective treatments, and will continue to work with researchers in academia and industry to design and conduct clinical studies towards achieving the goals of improving the health outcomes of people with ME/CFS, Long Covid and other post infection diseases.

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