On Oct. 6, 2021, AIM ImmunoTech released detailed safety data from a Phase 1 clinical study which supported the company’s belief that its drug Ampligen has significant potential as an intranasal therapeutic for COVID-19.

AIM previously announced that the study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy was completed, and that a Safety Report found the drug to be generally well tolerated and reported no Severe Adverse Events. More details are now being published on both the AIM website and on the website for the Centre for Human Drug Research (CHDR). A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms.

The biological samples are being analyzed for non-safety-related immunological activity, with results expected in Q4 2021.

Based on these positive safety results, AIM has moved forward in its efforts to develop Ampligen as a potential intranasal treatment for COVID-19, including:

• A Phase 2a Human Challenge Trial (HCT) to test Ampligen as a potential intranasal prophylactic using a human rhinovirus (HRV-16, a common cold virus) and influenza A virus (H3N2), which could help establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies, as well as mutations of known viruses such as SARS-CoV-2, which causes COVID-19
• A Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for two separate Phase 2 clinical studies to study the potential of Ampligen as both an intranasal and an infusion treatment for early-onset COVID-19
• The filing of a provisional patent application for Ampligen as a potential early-onset intranasal therapy designed to enhance and expand infection-induced immunity, epitope spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses