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May 27, 2021

AIM ImmunoTech reports positive safety data from Covid-19 trial

AIM ImmunoTech announces positive results from the third cohort in a Phase I study of its intranasal Ampligen for Covid-19.

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.

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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.

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COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
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