AIM ImmunoTech announced that that the first subjects have been dosed in a Phase 1 safety study of an intranasal formulation of the company’s Ampligen rintatolimod, which the company is developing for the prevention and/or treatment of COVID-19. AIM announced plans for the study in January 2021. According to AIM, in vitro modeling has demonstrated that “clinically achievable intranasal Ampligen dosage levels” could reduce viral yields of SARS-CoV-2 by 90%.
The 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,” is expected to enroll a total of 40 healthy subjects who will each receive seven doses of intranasal Ampligen or placebo over 13 days. The study is being conducted by the Centre for Human Drug Research (CHDR) in the Netherlands.
AIM CEO Thomas K. Equels said, “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 modeling 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.”
Read the AIM ImmunoTech press release.
