AIM ImmunoTech announced that the Centre for Human Drug Research (CHDR) will conduct a Phase 1 study of an intranasal formulation of the company’s Ampligen rintatolimod, which the company wants to develop for the treatment of COVID-19. IV Ampligen is currently approved in Argentina for the treatment of chronic fatigue syndrome, and AIM recently began treating some “long haul” post-COVID-19 patients experiencing chronic fatigue with Ampligen infusions under an expanded access program in the US.
The AMP-COV-100 (CHDR2049) 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 40 subjects, with 8 in each of 4 treatment groups and 8 in a placebo group. According to AIM, the study protocol has yet to be finalized.
Read the AIM ImmunoTech press release.