AIM ImmunoTech Inc. announced final clinical study results (AMP-518) for Ampligen in treating post-COVID conditions, specifically fatigue. The study, posted on ClinicalTrials.gov, reinforces the company’s belief in Ampligen’s potential for this indication. A new analysis from the NIH’s RECOVER initiative linking Long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) underscores the urgency of this research.
These findings are crucial due to the escalating prevalence of ME/CFS following COVID-19 infections. The increased patient population suffering from debilitating fatigue highlights the significant unmet medical need and the potential for Ampligen to address this growing health crisis. The connection between Long COVID and ME/CFS, now quantitatively established by the NIH RECOVER data, strengthens the rationale for developing targeted therapies like Ampligen. This emphasizes the potential for positive impact on a substantial patient group and positions AIM ImmunoTech at the forefront of addressing this challenge.
Analysis of the AMP-518 trial data reveals that Ampligen-treated Long COVID patients demonstrated improved performance in the Six-Minute Walk Test (6MWT). Patients with baseline 6MWT distances less than 205 meters experienced a mean improvement of 139 meters with Ampligen compared to 91 meters with the placebo (p<0.02). This suggests Ampligen may be particularly effective for patients with moderate to severe COVID-related fatigue or ME/CFS. Future trials will likely focus on this patient subgroup. This data, coupled with the growing recognition of Long COVID-induced ME/CFS, sets the stage for further development of Ampligen. The identified target patient group allows for more focused and potentially more successful clinical trials. This could accelerate the path towards regulatory approval and ultimately provide a much-needed treatment option for those suffering from debilitating post-COVID fatigue. Source link:
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
