A total of 80 subjects aged 18 to 60 years were enrolled in the planned, two-arm, placebo-controlled, multicentre, double-blind study.
They were randomised into a 1:1 ratio to receive either an intravenous infusion of Ampligen two times a week or a placebo for 12 weeks. Subjects will also be followed for two weeks post treatment.
The last patient of the study is expected to be dosed in the fourth quarter of this year, with topline data anticipated as early as in the first quarter of next year.
Change from baseline to week 13 in the PROMIS Fatigue Score is the trial’s primary protocol planned outcome measure.
Other protocol planned study outcomes include change from baseline to weeks six and 13 in distance travelled during a Six-Minute Walk Test, PROMIS Cognitive Function Score, and PROMIS Sleep Disturbance Score.
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Change from baseline to week six in PROMIS Fatigue Score and proportion of subjects that surpass 54m in the Six-Minute Walk Test at the end of treatment phase for 12 weeks are the other outcomes.
AIM ImmunoTech CEO Thomas Equels said: “We are incredibly pleased with the extremely rapid pace of enrolment for AMP-518.
“The completion of enrolment in such a short timeframe highlights the unmet medical need for a therapeutic option to treat Long Covid with chronic fatigue-like symptoms.
“We continue to be encouraged by the potential of Ampligen and are working diligently to bring this study across the finish line, with the ultimate goal of helping the millions of people struggling with this debilitating and life-altering syndrome.”
The lead product, Ampligen, is a dsRNA and highly selective TLR3 agonist immuno-modulator, exhibiting broad spectrum activity for viral diseases, immune system disorders, and various cancers.