AIM ImmunoTech has reported positive safety data from the third cohort in a Phase I AMP-COV-100 clinical study of its intranasal therapy, Ampligen, as a potential prophylaxis or treatment for Covid-19 and various respiratory viral diseases.
The randomised, double-blind, placebo-controlled trial analysed the safety, tolerability, and biological activity of repeated intranasal doses of Ampligen in healthy participants.
No serious adverse events linked to intranasal therapy were observed in the third cohort of the trial. The latest safety data is in line with results from the first two cohorts of the trial.
The study, sponsored and funded by AIM, is being carried out by the Centre for Human Drug Research (CHDR) in the Netherlands.
According to the study design, a total of 40 healthy participants were given repeated doses of either Ampligen or a placebo.
Participants in the first cohort were given 75μg Ampligen, the second cohort participants received 200μg Ampligen, and those in the third cohort were administered with a 500μg dose.
At present, the trial is continuing dosing in the fourth cohort, with subjects receiving 1250μg Ampligen.
All the trial participants will be given intranasal doses of the therapy every other day for 13 days, representing a total of seven doses for each individual.
Last month, AIM ImmunoTech reported positive safety data from the second cohort in the Phase I study.
According to previous in vitro modelling at The Institute for Antiviral Research at Utah State University in the US, Ampligen showed the potential to lower SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal dose levels.
The 90% effective concentration of Ampligen noticed in a tissue culture model of normal, human-derived tracheal/bronchial epithelial cells is achievable in humans clinically to possibly lower SARS-CoV-2, the company noted.