Benzinga | Apr 27, 2021 07:20AM EDT

AIM ImmunoTech Completes Dosing Of Cohort 2 In Phase 1 Study Of Ampligen, Reporting No Serious Adverse Events

AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed dosing of Cohort 2 in a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as an intranasal therapy, reporting no serious adverse events (SAE). AIM also reported no SAEs in Cohort 1. The study will proceed with enrollment into Cohort 3.



The clinical study is crucial for the company's ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study AMP-COV-100 (CHDR2049), 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." AIM is sponsoring and funding the clinical study.

The study protocol calls for a total of 40 healthy subjects to receive repeated administration of either Ampligen or a placebo. Subjects in Cohort 1 received 75 ?g of Ampligen, while subjects in Cohort 2 received 200 ?g of Ampligen. The dosage will escalate to 500 ?g in the next cohort, Cohort 3, with the highest level of 1250 ?g planned for Cohort 4.

AIM will continue to provide interim updates on the clinical trial.