AIM ImmunoTech has submitted a pre-investigational new drug (Pre-IND) application to the US Food and Drug Administration (FDA) for a study of Ampligen as a potential infusion treatment for post-Covid-19 cognitive dysfunction (PCCD).
The Phase 2, two-arm, randomised, double blind, placebo controlled, multicentre study will evaluate the efficacy and safety of Ampligen in 80 subjects suffering with PCCD.
This trial will see the subjects being randomised into a 1:1 ratio to get either twice weekly infusions of Ampligen or placebo for a period of twelve weeks.
Amarex Clinical Research, an NSF International firm, will manage the FDA submission as well as the study.
AIM ImmunoTech CEO Thomas Equels said: “This preliminary IND filing is not only a major milestone for the company, but also an important step forward for those individuals suffering from the debilitating long-term effects of Covid-19, including PCCD.
“We are highly encouraged by the outlook for this trial based on the safety data we have amassed around Ampligen, combined with initial data suggesting that Ampligen may improve cognitive function among patients with PCCD.”
People suffering with PCCD, including young adults, can have trouble in concentrating, serious memory problems and inability to live an active lifestyle.
According to the initial data, patients with PCCD symptoms treated with Ampligen in the AMP-511 Early Access Program, showed enhancements in concentration or focusing ability.
The AMP-511 Early Access Program is currently underway.
AIM filed a provisional patent application for Ampligen as an intravenous and intranasal treatment for PCCD based on these findings and research.
In April this year, AIM announced that no serious adverse events were seen in Cohort 1 of a Phase I AMP-COV-100 (CHDR2049) clinical trial of its drug Ampligen as an intranasal therapy for the treatment of Covid-19.