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.
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.
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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.