AIM ImmunoTech Inc (NYSE:AIM). said it has signed a signed clinical trial agreement for a Phase 2a Human Challenge Trial (HCT) with hVIVO for a Phase 2a Human Challenge Trial (HCT) to test the company’s flagship drug Ampligen as a potential intranasal prophylactic using a human rhinovirus (HRV-16, a common cold virus) and influenza A virus (H3N2).
The Ocala, Florida-based immuno-pharma company said the antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan PLC (AIM:ORPH, FRA:CRO), a rapidly growing clinical research organization and leader in vaccine and antiviral testing using human challenge clinical trials. The study is expected to start in the fourth quarter of 2021.
On September 20, AIM ImmunoTech revealed 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,” said the company.
READ: AIM ImmunoTech well positioned with $57.3M to advance clinical trials of flagship drug Ampligen
The Phase 2a HCT is a single-center, prospective, randomized, double-blind, placebo-controlled study of Ampligen given 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, to assess whether there is a prophylactic effect,” said the company.
A total of 64 participants are likely 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 for a total of 64 evaluable participants. In each group, 16 participants will be receiving Ampligen and 16 participants will be receiving a placebo.
hVIVO has two decades of experience 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 which causes coronavirus (COVID-19).
AIM ImmunoTech said that 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.
“Exploratory endpoints are designed to develop data related to Ampligen’s potential ability to confer enhanced and expanded immunity post-infection,” noted the company.
AIM ImmunoTech is focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including coronavirus.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive