AIM ImmunoTech has submitted an application to the US Food and Drug Administration (FDA) to study Ampligen as a potential infusion treatment for post-Covid-19 cognitive dysfunction (PCCD).
The company submitted the Pre-Investigational New Drug application (Pre-IND) for a Phase II, two-arm, randomised, double-blind, placebo-controlled, multicentre trial to assess the efficacy and safety of Ampligen in 80 subjects with PCCD.
During the trial, the subjects will be randomised into a 1:1 ratio to receive either twice-weekly infusions of Ampligen or placebo for a 12-week period.
The FDA submission, as well as the trial, will be managed by Amarex Clinical Research, an NSF International company, AIM noted.
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.”
Individuals with PCCD, including young adults, can have trouble concentrating, serious memory problems and the inability to work and live an active lifestyle and face issues in completing daily tasks.
As per the initial data, patients with PCCD symptoms treated with Ampligen in the AMP-511 Early Access Program, which is currently underway, showed enhancements in concentration or focusing ability.
Based on these findings and research conducted by the company, AIM filed a provisional patent application for Ampligen as an intravenous as well as intranasal treatment for PCCD.
In April, AIM reported that no serious adverse events were observed in Cohort 1 of a Phase I AMP-COV-100 (CHDR2049) clinical study of its drug Ampligen as an intranasal therapy for Covid-19.