Benzinga | Sep 30, 2021 06:03AM EDT

AIM ImmunoTech Announces Clinical Trial Agreement For A Phase 2a Human Challenge Trial Of Ampligen as a Potential Intranasal Prophylaxis Against Respiratory Viruses

AIM ImmunoTech Inc. (NYSE:AIM) today announced that AIM and hVIVO have a signed Clinical Trial Agreement (CTA) for a Phase 2a Human Challenge Trial (HCT) to test the company's drug Ampligen as a potential intranasal prophylactic using a human rhinovirus (HRV-16, a common cold virus) and influenza A virus (H3N2).

This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organization and world leader in vaccine and antiviral testing using human challenge clinical trials. The AIM-sponsored study is expected to start in Q4 2021.

AIM announced on September 20 that the proposed protocol for the study had been submitted to the Oxford Research Ethics Committee/Medicines and Healthcare Regulatory Agency. The committee met last week and its response is expected by mid November. Preparations to commence the study are now underway, pending the expected approval.

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 AIM 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.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus), malaria, asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.

A successful Phase 2a study could also 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.

Further, exploratory endpoints are designed to develop data related to Ampligen's potential ability to confer enhanced and expanded immunity post-infection.