AIM ImmunoTech Inc (NYSE:AIM). provided a status update on its Phase 2a Human Challenge Trial (HCT) to test the company’s flagship drug Ampligen as a potential intranasal prophylactic therapy using a human rhinovirus (HRV-16), which is a common cold virus, and influenza A virus (H3N2).
The Ocala, Florida-based immuno-pharma company said the proposed protocol for its 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, and the response is expected by mid-November,” said the company.
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In addition, the AIM ImmunoTech said it is working with Open Orphan PLC (AIM:ORPH, FRA:CRO)'s subsidiary hVIVO to finalize the details of a clinical trial agreement (CTA). hVIVO is a specialist contract research organization and leader in vaccine and antiviral testing using human challenge clinical trials.
“The study should move forward quickly once we have the expected approval of the REC/MHRA and our final agreement with hVIVO,” said the company.
The Phase 2a HCT is a single-center, prospective, randomized, double-blind, placebo-controlled study of Ampligen administered intranasally to healthy adult 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 expected to enroll in the 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. In each group, 16 participants will receive Ampligen and 16 participants will get a 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 coronavirus (COVID-19).
In a statement, AIM CEO Thomas K Equels said: “We are excited to advance this Human Challenge Trial using Ampligen. Assuming we are successful, we believe this trial could have significant implications in the fight against infectious, viral respiratory diseases and future pandemics.”
“Specifically, there is a major unmet need for a prophylactic therapy that could be easily administered to patients prior to exposure to respiratory viruses such as influenza, coronaviruses and even rhinoviruses such as the common cold. We look forward to partnering with hVIVO on this landmark trial,” he added.
AIM ImmunoTech is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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