AIM ImmunoTech Begins Dosing for Intranasal Ampligen Clinical Study

AIM ImmunoTech has 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 ‘s goal is to develop Ampligen as a potential intranasal prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases.

Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study, titled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects.”

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.

“We greatly appreciate the tremendous efforts of the entire team at CHDR to help us initiate our Phase 1 study of Ampligen as a potential intranasal therapy. Our objective is to expedite the development of Ampligen as a potential prophylaxis or treatment for COVID-19. Prior results of in vitro modelling were promising, and we are highly encouraged by the potential of an intranasal prophylactic approach using Ampligen to prevent infection and spread of COVID-19. We look forward to providing further updates as this critical trial progresses,” Thomas K. Equels, CEO of AIM said.