AIM Immunotech has submitted a pre-investigational new drug application (Pre-IND) to the US Food and Drug Administration (FDA) to conduct two separate Phase II clinical trials of Ampligen to treat Covid-19.
The randomised, double-blind, placebo-controlled Phase II trials intend to analyse the efficacy and safety of Ampligen as an infusion and an intranasal therapy for early-onset Covid-19.
For the Phase II Ampligen intravenous therapy trial, subjects will receive five doses of either 200mg Ampligen or placebo for 17 days.
The intranasal Ampligen trial will analyse seven doses of a 1,250 microgram (μg) spray or 625μg per nostril of the drug over a treatment duration of 15 days.
Apart from evaluating the efficacy and safety, the new Phase II protocols will also include exploratory goals that AIM estimates to support its lately filed provisional patent application.
AIM ImmunoTech CEO Thomas Equels said: “With Ampligen’s recently established intranasal safety profile, and the preliminary results from these trials, we may be able to show that Ampligen not only has an early-onset therapeutic effect against a broad spectrum of respiratory viruses but also may provide a boost to post-infection immunity that will confer cross-protection against viral variants.
“We believe the clearly defined exploratory endpoints for the upcoming trials will substantially validate the significant potential of Ampligen.”
This June, AIM reported that all subjects received treatment in a Phase I trial to analyse the safety, tolerability and biological activity of Ampligen as a potential intranasal treatment.
A total of 40 healthy subjects enrolled in the trial were given either Ampligen or a placebo, with the former administered at four escalating doses across four cohorts to a maximum dose of 1,250μg.
No severe adverse events at any dose level were reported in the trial.
This May, AIM reported positive safety data from the third cohort in a Phase I AMP-COV-100 clinical study of Ampligen as a potential prophylaxis or treatment for Covid-19 and various respiratory viral diseases.