AIM ImmunoTech has reported positive initial pilot study data from its ongoing Expanded Access Program (EAP or AMP-511), a Phase III clinical trial of an investigational drug, Ampligen, for long Covid.
The multicentre, prospective, open-label trial is analysing Ampligen for treating patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
It was modified in October 2020 to include patients who have had Covid-19 following virus clearance. These patients showed chronic fatigue-like symptoms called post-Covid conditions.
Four post-Covid patients were treated in the amendment ‘pilot’ programme.
Under the amendment, subjects are required to meet the 1988 or 1994 CDC Case Definition for CFS.
They receive intravenous (IV) dose of Ampligen twice a week and if well-tolerated, the dose will escalate up to 400mg.
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According to findings from this uncontrolled trial, subjects had statistically significant improvements in chronic fatigue following Ampligen treatment.
The company is working towards submitting an investigational new drug (IND) application to the Food and Drug Administration for a Phase II controlled trial of Ampligen given for 12 weeks to treat post-Covid conditions.
Ampligen modulates the immune system and has shown antiviral activity.
AIM ImmunoTech CEO Thomas Equels said: “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.
“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.”
In May this year, the company provided an update on its ongoing efforts to develop an effective treatment for long Covid with Ampligen.