AIM ImmunoTech Announces PLOS ONE’s Publication of New Data Analyses Showing Importance of Disease Duration on Ampligen’s Positive Role in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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OCALA, Fla., Nov. 02, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) announced today the publication of statistically significant data detailing how its drug Ampligen could have a considerable positive impact on people living with the debilitating illness myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) when administered in the early stages of the disease. The data were published in PLOS ONE, a peer-reviewed open access scientific journal published by the Public Library of Science.

AIM researchers found that the TLR3 agonist Ampligen substantially improved physical performance in a subset of ME/CFS patients. Analysis of Exercise Treadmill Testing (ETT) data from its Phase III trial has identified a subset of patients with at least a two-fold increased exercise response to Ampligen.

Study Analysis

The ME/CFS population of 208 subjects was divided into two subsets based on symptom duration. The Target subset consisting of 75 patients with ME/CFS symptom duration of 2-8 years was compared to a Non-Target subset consisting of 133 patients with symptom duration outside of the 2-8-year range. Researchers identified 2-8 years as the preferred Target subset for the data analysis in an attempt to reduce possible cases of spontaneous remission after disease onset, while still including several years for ME/CFS symptoms to persist.

The placebo-adjusted percentage increase in ETT and the vertical rise in feet while exercising on the treadmill in the Target subset were both at least twice that seen for the combined population of 208 subjects. While no clinically significant ETT response was seen in the Non-Target subset, within the Target subset, 51.2% of the Ampligen-treated subjects improved their exercise duration by at least 25% (p=0.003, a statistically significant value). This magnitude of exercise improvement was associated with additional measures of improved quality of life, including an ability to ascend the equivalent of nearly 175 more vertical feet at Week 40 when compared to the baseline value before the Ampligen treatment was started. The analysis indicates that there may be a relatively short disease duration window early in the course of the disease (before eight years) in which ME/CFS patients may see a significant clinical response.