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May 19, 2022

AIM ImmunoTech provides Phase III efficacy update on Ampligen for long Covid

Treatment with investigational drug Ampligen for a minimum of 12 weeks offered a decline in fatigue in long Covid patients.

AIM ImmunoTech has offered an update on its efforts underway for developing an effective treatment for long Covid with its investigational drug, Ampligen.

The current list of long Covid (Post-Covid) conditions of the Centers for Disease Control and Prevention (CDC) comprises 18 different health issues. Nearly one-half of these symptoms are similar to those observed in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) patients. 

Rintatolimod (Ampligen) offered objective improvement in exercise tolerance in a prospective, randomised, double-blind, placebo-controlled Phase III AMP-516 clinical trial in ME/CFS.

A statistically significant 51.2% positive response was seen in assessment in a subset of trial subjects with early symptom development.

In an amendment to the AIM’s Food and Drug Administration (FDA) authorised AMP-511 expanded access programme (EAP) underway, the company enrolled four post-Covid patients with new ME/CFS onset after acute Covid-19 infection. 

AMP-511 is an open-label study of Ampligen in subjects with severely debilitating CFS/ ME.

After treatment with Ampligen for a minimum of 12 weeks, each of these four subjects reported a decline in fatigue, as evaluated through Patient-Reported Outcomes questionnaires. 

An assessment of these findings showed that the reduction in fatigue versus baseline was statistically significant irrespective of the limited number of trial subjects.

Partly based on these positive results, the company intends to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for a Phase II clinical trial of Ampligen to treat long Covid conditions. 

The scheduled IND is for 12 weeks of treatment with Ampligen.

AIM chief medical officer David Strayer said: “Evidence from the AMP-516 study indicated that severe ME/CFS patients with a shorter time from onset of ME/CFS symptoms as a group responded better than those with a longer duration of illness. 

“Although the time scale is much more condensed, the results from these four patients indicating improvement in fatigue in only 12 weeks is consistent with the hypothesis that a shorter duration of illness prior to treatment may improve responses to Ampligen.”

In May last year, the company reported positive safety data from the third cohort in a Phase I AMP-COV-100 trial of intranasal therapy, Ampligen, as a potential prophylaxis or treatment for Covid-19.

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