AIM ImmunoTech Plans To Evaluate Two Forms Of Ampligen In Early-COVID-19 Disease

AIM ImmunoTech Inc AIM submitted a Pre-Investigational New Drug Application (Pre-IND) to the FDA for COVID-19 trials with Ampligen.
The application is for two separate Phase 2 clinical studies to study the potential of Ampligen as both an infusion and an intranasal therapy for early-onset COVID-19.
Related Link: AIM ImmunoTech Receives Positive FDA Response For Ampligen Trial In PCCD Patients.
Intravenous therapy trial will assess 200 mg of Ampligen or placebo, with five doses over a treatment period of 17 days.
Intranasal therapy study will evaluate 1,250 μg spray (625 μg per nostril), with seven doses over a treatment period of 15 days.
In addition to studying efficacy and safety, the new Phase 2 protocols include exploratory endpoints that the company believes could support its recently filed provisional patent application.
Ampligen demonstrated a 100% protective survival benefit compared to 100% mortality in a saline control group in animal studies.
Ampligen also reduced SARS-CoV-1 lung titers to below the level of detection.
Related content: Benzinga's Full FDA Calendar.
Price Action: AIM stock is 1% at $1.99 during the market session on the last check Tuesday.