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April 28, 2021

AIM ImmunoTech reports positive data from intranasal Covid-19 trial

AIM ImmunoTech has reported positive safety data from cohort 2 in a Phase I study of its intranasal Ampligen therapy as a potential prophylaxis or treatment for Covid-19 and other respiratory viral diseases.

AIM ImmunoTech has reported positive safety data from cohort 2 in a Phase I study of its intranasal Ampligen therapy as a potential prophylaxis or treatment for Covid-19 and other respiratory viral diseases.

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The study, named ‘A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects’, is being carried out by the Centre for Human Drug Research (CHDR) institute in the Netherlands.

The AIM ImmunoTech-funded trial has been designed to analyse the safety, tolerability and biological activity of repeated doses of intranasal Ampligen.

It will enrol a total of 40 healthy participants who will receive repeated doses of either Ampligen or a placebo.

Subjects in Cohort 1 received 75μg Ampligen, while those in Cohort 2 were given 200μg Ampligen.

They received intranasal doses of the therapy every other day for 13 days.

The latest safety data showed that no serious adverse events (SAE) linked to Ampligen were reported in Cohort 2 of the trial.

AIM ImmunoTech noted that no SAEs were observed in Cohort 1 either.

With the latest development, the dosage will be increased to 500μg in Cohort 3, while the highest level of 1,250μg Ampligen is planned for Cohort 4.

The trial will now proceed with subject enrolment into Cohort 3.

The company will continue to report interim updates on the clinical trial.

Ampligen was shown to lower SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal dose levels in prior in vitro modelling at The Institute for Antiviral Research at Utah State University.

Last month, AIM ImmunoTech dosed the first healthy participants in a Phase I study of Ampligen as a potential intranasal prophylaxis or early-stage treatment for Covid-19 and other respiratory viral diseases.

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Reshape regional strategies to navigate global uncertainties

The COVID-19 crisis triggered one of the worst peacetime recessions globally. Even as several economies tread the path to recovery, the surge in COVID-19 cases and emergence of new variants, coupled with geopolitical tensions, will continue to cloud the global outlook.  The Global Risk report uses GlobalData’s proprietary Country Risk Index to determine the existing and future level of global risk by assessing over 50 key indicators, including:  
  • Macroeconomic 
  • Political 
  • Social
  • Technological 
  • Environmental 
  • Legal 
Use our Country Risk Index scores to help you understand future global risk and determine your business strategies, growth plans and investment portfolios. 
by GlobalData
Enter your details here to receive your free Report.

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