AIM ImmunoTech Inc (NYSE:AIM) has announced that it is working towards filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for its long COVID investigational drug Ampligen, partly based on positive early data from its ongoing clinical trial.
The company said it had amended its ongoing FDA-authorized AMP-511 trial to enroll four post-COVID patients with new onset myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) following acute COVID-19.
According to AIM, of the CDC’s current list of 18 post-COVID conditions, approximately one-half of these overlap with symptoms seen in patients with ME/CFS, which a Phase 3 trial (AMP-516) of Ampligen produced an objective improvement in exercise tolerance.
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“Following at least 12 weeks of Ampligen treatment, each of these four patients indicated they had experienced a reduction in fatigue, as measured via patient-reported outcomes questionnaires,” the company said.
“A statistical analysis of these data indicated that the decrease in fatigue compared to baseline was statistically significant (p<0.003), despite the small number of patients.”
Based in part on this early positive data, AIM said it was working towards filing an IND application with the FDA for a Phase 2 study involving 12 weeks of Ampligen therapy for the treatment of post-COVID conditions.
AIM chief medical officer David Strayer said the company believed the results were especially encouraging and justified conducting a placebo-controlled study to attempt to confirm the findings.
“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,” Strayer said.
“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.”
Principal Investigator for AMP-511 at the Hunter-Hopkins Center in Charlotte Charles Lapp said the trial had been so successful that two of the participants had asked to continue Ampligen therapy.
“I have been very pleased with these results and see potential for the therapeutic benefit of Ampligen in other persons with long COVID,” Lapp said.
Based in Ocala, Florida, AIM ImmunoTech is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral disorders, including COVID-19.
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