FDA Approves Ampligen Trial to Treat Long COVID & ME/CFS

AIM ImmunoTech Hopes to Start Patient Enrollment in 2023

In October 2022, an immuno-pharma company known as AIM ImmunoTech received approval from the FDA to start its Phase 2 study to evaluate their Investigational New Drug (IND), Ampligen, as a potential treatment for long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

If all goes well in the 2023 trial, Ampligen will likely be advanced as a potential therapeutic for the treatment of long COVID and ME/CFS. Based on prior studies, ImmunoTech is under the belief that Ampligen could be an effective treatment option and an important solution for patients and physicians alike.

The company expresses that it is “deeply grateful” for the recent FDA clearance and “is working to get the study up and running as quickly and efficiently as possible.” Assuming all goes smoothly, ImmunoTech hopes to commence patient enrollment in early 2023.

Post-COVID Conditions Are “a Serious Public Health Crisis”

Following the coronavirus pandemic in 2020, the company quickly identified post-COVID conditions (long COVID symptoms) as an “unmet need” in American society.

"Post-COVID conditions continue to present a serious public health crisis," says Oved Amitay, Ph.D., President & CEO of the advocacy organization Solve M.E. "[There] remains an ongoing struggle for patients to access safe and effective therapeutics." He adds that to effectively address this unmet need, we must apply existing knowledge, such as previous studies conducted for ME/CFS.

How Has Ampligen Impacted Patients with ME/CFS?

Fortunately, Ampligen has yielded promising results in previous trials involving patients affected by ME/CFS, a serious long-term illness that affects many body systems and causes severe fatigue and sleep problems.

In its ME/CFS trials, Ampligen demonstrated an encouraging safety profile and was well tolerated by participants. Data from the most recent study regarding long COVID yielded a similarly encouraging profile and was also well tolerated by those suffering from post-COVID conditions. In fact, a recent subgroup analysis revealed a response rate greater than 50% with “a statistically significant response” in those treated closer to the onset of their infection.

Dr. Oved Amitay responded to this data with the following comment: “Given the possibility of earlier intervention, [we] believe that this study is an important step in addressing the needs of people with these post-infection debilitating symptoms [of long COVID and ME/CFS].”

What Will the Ampligen Phase 2 Study Look Like?

Phase 2 of the Ampligen study is to be a two-arm, randomized, double-blind, placebo-controlled, multicenter study. Its purpose is to evaluate the safety and efficacy of Ampligen in patients with chronic fatigue as a result of long COVID—the same symptom faced by those with ME/CFS.

The study hopes to improve outcomes that involve the following:

Lessened fatigue
Greater distance traveled
Improved cognitive function
Reduced sleep disturbance

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