Benzinga | Feb 16, 2021 09:36AM EST

AIM ImmunoTech Reports Its Ethics Committee Has Approved Commencement Of Phase 1 Study Of Ampligen As An Intranasal Therapy

AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has received approval from the required Ethics Committee in the Netherlands to commence its Phase 1 clinical study on the safety of AIM's drug Ampligen as an intranasal therapy, a critical step in the company's ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

Earlier this year, the company announced that it had entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) trial. Last week, approval was received from the Dutch local Ethics Committee, clearing the road for execution of the trial.

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. This will 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.

"We are delighted and honored to receive Ethics Committee approval, an important step toward initiation of the trial," said AIM CEO Thomas K. Equels. "We are on track for site initiation later this month and expect to begin enrolling participants in the study during the first quarter of 2021. Importantly, our 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 concentrations. As a result, we are highly encouraged by the potential of an intranasal prophylactic approach using Ampligen to prevent infection and spread of COVID-19 and are excited to commence safety tests of potential dosing regimens."

Dr. Matthijs Moerland, principal investigator at CHDR: "We're very happy helping AIM with this important step. Together with AIM's study team, we feel we have not only designed a trial evaluating Ampligen's intranasal safety profile, but also yielding important mechanistic data on the compound's immunomodulatory activities."