AIM ImmunoTech's final clinical study results for AMP-518, evaluating Ampligen in patients with Post-COVID Conditions, have been posted on ClinicalTrials.gov, revealing the drug's potential in treating moderate-to-severe fatigue. The data suggests that Ampligen could offer a therapeutic benefit, particularly for individuals experiencing significant fatigue post-COVID-19.
AMP-518 Trial Results
In the AMP-518 Phase 2 clinical trial, patients treated with Ampligen demonstrated improvements in the Six-Minute Walk Test (6MWT) compared to those who received a placebo. The 6MWT, which measures the distance a subject can walk in six minutes, was assessed at baseline and again at 13 weeks.
Further analysis revealed a significant signal (p < 0.02, two-tailed T-test) in Ampligen-treated subjects with a baseline 6MWT of less than 205 meters. This group experienced a mean improvement of 139 meters, compared to a mean improvement of 91 meters in the placebo group.
Implications for Future Trials
"The results of AMP-518 support AIM’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue," said CEO Thomas K. Equels. "Our analysis of the final Clinical Study Results has helped us to identify a likely subject population that would experience the greatest benefit from Ampligen in AIM’s planned follow-up clinical trial."
AIM ImmunoTech intends to focus future trial designs on Ampligen's therapeutic potential for subjects whose COVID-related fatigue or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) symptoms can be categorized as moderate or worse.
Link Between Long COVID and ME/CFS
The AMP-518 data is supported by a new analysis of data from the National Institutes of Health RECOVER initiative, demonstrating a clear link between Long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. The report found that the prevalence of patients who met the 2015 Institute of Medicine ME/CFS clinical diagnostic criteria is five times higher than before the start of the COVID-19 pandemic, suggesting a considerable increase in the number of patients that could be classified as having ME/CFS resulting from their COVID-19 infection.
About Ampligen
Ampligen (rintatolimod) is a first-in-class investigational drug, a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
