AIM ImmunoTech Inc (NYSE:AIM) has announced what it calls positive preliminary pilot study data from its ongoing Expanded Access Program (EAP) evaluating its investigational drug Ampligen as a therapeutic for Long COVID.
The immuno-pharma firm said the preliminary data from this uncontrolled clinical trial found that patients reported statistically significant improvements in chronic fatigue after treatment with Ampligen and, based on these early results, the company is working to move forward with a Phase 2 controlled trial.
“The positive preliminary data demonstrated in this pilot study bolsters our confidence in the potential of Ampligen as we continue to drive its development as a potential therapeutic for the treatment of long COVID,” AIM ImmunoTech CEO Thomas Equels said in a statement.
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“With the positive preliminary results demonstrated to date, we remain, now more than ever, steadfast in our mission to bring an effective therapeutic option to those in need,” Equels added.
AIM ImmunoTech noted that Ampligen, which modulates the immune system and has demonstrated antiviral activity, is the company’s ribonucleic acid (RNA) product candidate being developed for globally important cancers, viral diseases and disorders of the immune system.
The company added that based in part on these early positive data, it is continuing to work toward filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a Phase 2 study of Ampligen for the treatment of post-COVID conditions.
The planned IND is for 12 weeks of therapy, AIM ImmunoTech said.
Based in Ocala, Florida, AIM ImmunoTech is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral disorders, including COVID-19.
Contact Sean at sean@proactiveinvestors.com