AIM ImmunoTech provides an update on Ampligen for a long Covid treatment

AIM ImmunoTech has offered an update on its ongoing efforts to develop an effective treatment for long Covid with its investigational drug Ampligen.

The Centers for Disease Control and Prevention’s (CDC) current list of long-standing Covid (post-Covid) illnesses includes 18 different health problems. Almost half of these symptoms are similar to those seen in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

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

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

In an ongoing amendment to the Food and Drug Administration’s (FDA)-approved AMP-511 Expanded Access Program (EAP), the Company has treated four post-Covid patients with new onset ME/ CFS recorded after acute Covid-19 infection.

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

After at least 12 weeks of treatment with Ampligen, each of these four subjects reported a reduction in fatigue, as assessed using patient-reported outcome questionnaires.

An evaluation of these results showed that the reduction in fatigue from baseline was statistically significant, regardless of the limited number of study participants.

Based in part on these positive results, the Company intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial of Ampligen for the treatment of long-term Covid disease.

The planned IND includes 12 weeks of treatment with Ampligen.

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

“Although the time scale is much more compressed, the results from these four patients, showing improvement in fatigue in just 12 weeks, are consistent with the hypothesis that shorter disease duration prior to treatment may improve response to Ampligen.”

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


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