AIM ImmunoTech Inc. (AIM) said that it has signed a contract to sponsor a Phase 2a Human Challenge Trial to test the company's drug Ampligen as a potential intranasal antiviral therapy using a human Rhinovirus hRV--common cold virus-- and Influenza.
hVIVO, a subsidiary of Open Orphan plc, will conduct the antiviral study. The trial is expected to commence in the fourth-quarter of 2021.
The company noted 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 known viruses such as SARS-CoV-2, which causes COVID-19.
A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level. A final study report is expect in the third quarter of 2021.
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