Benzinga | Sep 28, 2021 02:50PM EDT

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

* AIM ImmunoTech Inc (NYSE: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 ?g spray (625 ?g 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.