AIM ImmunoTech has announced that it will definitely advance an intranasal formulation of its Ampligen rintatolimod into a Phase 2 trial after the initial dose tested in a Phase 1 study showed no safety problems. The company announced initiation of the Phase 1 study, which is set to enroll 40 healthy subjects, in March 2021. The Phase 1 study began with a 75 μg dose and is set to escalate to 200, 500, and 1250 μg doses. AIM plans to develop intranasal Ampligen for the prevention or treatment of COVID-19 and other respiratory viruses.
AIM CEO Thomas K. Equels commented, “AIM is pleased with the positive results in this first cohort. This Phase 1 safety study is designed to test the parameters of Ampligen’s intranasal tolerance before commencing a Phase 2 study. While the higher doses that we plan to test in this Phase 1 trial may or may not be well tolerated, we plan on moving quickly into Phase 2 studies with the doses that have successfully passed these Phase 1 tests, such as the dose used in Cohort 1.”
Read the AIM ImmunoTech press release.
