AIM ImmunoTech Inc. provided a status update on its phase 2a human challenge trial (HCT) to test the company’s drug Ampligen as a potential intranasal prophylactic therapy using a human rhinovirus (HRV-16, a common cold virus) and influenza A virus (H3N2). The proposed protocol for the company-sponsored study was submitted to the Oxford Research Ethics Committee (REC)/Medicines and Healthcare Regulatory Agency (MHRA) on September 10, 2021. A meeting is scheduled to review the study on September 24, 2021, and the response is expected by mid November 2021. In addition, the company and hVIVO continue to work to finalize the details of a clinical trial agreement (CTA) and hope to announce its signing soon. The study should move forward quickly once the company has the expected approval of the REC/MHRA and its final agreement with hVIVO. The phase 2a HCT is a single center, prospective, randomized, double-blind, placebo-controlled study of Ampligen administered intranasally to healthy adult male and female participants. In an HCT, subjects are intentionally exposed to particular diseases to test how the diseases will respond to potential therapeutics. An HCT will allow the company to expedite the development process for Ampligen by ensuring full exposure of both the control group and the Ampligen group, so as to assess whether there is a prophylactic effect. A total of 64 participants are planned to participate in this study; 32 participants will be randomized and inoculated with influenza A/Perth/16/2009 (H3N2) and 32 participants will be randomized and inoculated with HRV-16 for an estimated total of 64 evaluable participants. In each group, 16 participants will be receiving Ampligen and 16 participants will be receiving placebo. A successful phase 2a study could also 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 known viruses such as SARS-CoV-2, which causes COVID-19.