On Mar. 8, 2021, AIM ImmunoTech announced that it had dosed the first healthy subjects in its Phase 1 clinical study on the safety of AIM’s drug Ampligen as a potential intranasal therapy. AIM’s goal was to develop Ampligen as a potential intranasal prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases.

The current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and eight placebo subjects, for a total of 40 healthy subjects. The trial is designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. AIM is funding the clinical study.

The prior in vitro modeling at The Institute for Antiviral Research at Utah State University demonstrated that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.