On Sept. 28, 2021, AIM ImmunoTech announced that is had submitted a Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration for two separate Phase 2 clinical studies to study the potential of Ampligen as both an infusion and an intranasal therapy for early-onset COVID-19, the disease caused by SARS-CoV-2.

The two clinical trials will be Phase 2, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of Ampligen as an:

• Intravenous therapy – 200 mg of Ampligen or placebo, with five doses over a treatment period of 17 days; and an
• Intranasal therapy – 1,250 μg spray (625 μg per nostril), with seven doses over a treatment period of 15 days.

In addition to studying efficacy and safety, the new Phase 2 protocols include exploratory endpoints that the company believes could support its recently filed provisional patent application.

AIM believes that it is critical to test the potential of Ampligen as both an intravenous and an intranasal therapy for early-onset COVID-19, as there is science to support the potential of both approaches.