The trial is designed to assess the safety and efficacy of Ampligen in people with post-Covid fatigue. Credit: Theera Disayarat / Shutterstock.com.

AIM ImmunoTech has concluded subject dosing in the Phase II clinical trial of its investigational drug, Ampligen, to treat individuals with post-Covid fatigue. 

The randomised, two-arm, placebo-controlled, double-blind, multicentre AMP-518 trial is designed to assess the safety and efficacy of Ampligen.

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Variation in the PROMIS Fatigue Score from baseline to week 13 is the trial’s primary protocol planned outcome measure.

The company concluded subject enrolment for the trial in August this year. 

It enrolled 80 participants aged 18 to 60 years, who were randomised into a 1:1 ratio to receive intravenous doses of Ampligen or placebo twice a week for a total of 12 weeks.

These subjects will also be followed up for another two weeks in the trial.

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AIM ImmunoTech noted that no severe adverse events related to Ampligen treatment were observed in the trial. 

The company anticipates reporting topline findings from the trial in the first quarter of next year.

AIM ImmunoTech CEO Thomas Equels said: “With dosing now complete, our AMP-518 focus turns to the next milestone of being able to report topline study data as soon as it is available. 

“We continue to believe in the potential of Ampligen to provide a much-needed therapeutic option to treat long Covid with chronic fatigue-like symptoms. 

“Post-Covid conditions have emerged as a serious public health threat and a clear public need.”

A dsRNA and TLR3 agonist immuno-modulator, Ampligen showed to possess broad spectrum activity in trials for these indications.

The company focuses on developing treatments for various cancer types, immune disorders, and viral diseases, including Covid-19.