AIM ImmunoTech has received approval from the central Institutional Review Board (IRB) in the US for the protocol of its Phase ll AMP-518 clinical trial of Ampligen to treat patients with post-Covid conditions.
The approval helps AIM to commence the process of selecting sites for the trial. It comes after the firm unveiled its plan to start the trial for long Covid fatigue, in August last year.
The two-arm, randomised, double-blind, placebo-controlled, multicentre AMP-518 trial aims to assess the efficacy and safety of Ampligen in patients with post-Covid fatigue.
Its primary outcome is change from baseline to week 13 in PROMIS Fatigue Score.
Other objectives of the trial are change from baseline to week six in PROMIS Fatigue Score, change from baseline to weeks six and 13 in distance covered during a six-minute walk test as well as in PROMIS Sleep Disturbance Score, among others.
AMP-518 plans to include around 80 subjects within the age group of 18 to 60 years at up to 10 sites in the US.
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During the trial, patients will be randomised into 1:1 ratio to get twice weekly IV infusions of either Ampligen or placebo for 12 weeks with two weeks follow up period.
Enrolment of patients and dosing in the trial is anticipated to start in the second quarter of this year.
AIM ImmunoTech CEO Thomas Equels said: “We continue to be encouraged by the pilot data demonstrated to date and believe Ampligen has the potential to meet an important growing unmet medical need, with a patient population that exceeds several million in the US alone, with even more worldwide.
“With central IRB approval, our team is working toward getting our pre-selected sites open so that patient enrolment and dosing can be up and running as quickly and efficiently as possible.”