AIM ImmunoTech announced it will participate in an event hosted by Solve M.E. Diagnostics and The Biotechnology Innovation Organization titled, "Long Covid: What Will It Take To Accelerate Therapeutic Progress?," being held virtually on Tuesday, February 21, 2023, from 10:00 AM – 1:00 PM PT. The goal of the virtual event is to convene stakeholders to advance research and development to diagnose and treat Long Covid, ME/CFS, and post-infection diseases. By increasing awareness among drug developers to the unmet needs of our communities, Solve M.E. hopes to inspire industry players to study these diseases and create therapeutic breakthroughs. The session will also feature solution-oriented perspectives from government, academic, and industry researchers; patient groups; funding sources; and policymakers. As part of the event, Thomas Equels, CEO of AIM ImmunoTech, will discuss the clinical development plans for Ampligen for the treatment of ME/CFS and Long COVID. Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. The Company is currently sponsoring an ongoing, FDA-authorized AMP-511 Expanded Access Program for ME/CFS patients in the United States, which has been amended to include Long COVID patients. Preliminary results based on data from the first 4 Long COVID patients, following at least 12 weeks of Ampligen treatment, indicated they had experienced a reduction in fatigue, as measured via Patient-Reported Outcomes questionnaires. A statistical analysis of these data indicated that the decrease in fatigue compared to baseline was statistically significant, despite the small number of patients. Based in part on these early positive data, the FDA provided clearance of the Company’s IND application for a Phase 2 study of Ampligen for the treatment of Post-COVID Conditions. The Company expects to commence patient enrollment in AMP-518 in Q1 2023.
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