With this latest development, the company will soon initiate dose escalation in Cohort 2 of the trial. Credit: Gerd Altmann / Pixabay.

AIM ImmunoTech has reported that no serious adverse events were observed in Cohort 1 of a Phase I AMP-COV-100 (CHDR2049) clinical study of its drug Ampligen as an intranasal therapy for Covid-19.

With this latest development, the company will soon initiate dose escalation in Cohort 2 of the trial.

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AIM is developing Ampligen as potential Covid-19 prophylaxis or treatment as well as for other respiratory viral diseases.

Named ā€˜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 Subjectsā€™, the trial is being carried out by the Centre for Human Drug Research (CHDR) in Leiden, Netherlands.

Sponsored and funded by AIM, the study will have a total of 40 healthy participants. Eight people will be enrolled on each of the four cohorts to receive 75Ī¼g, 200Ī¼g, 500Ī¼g and 1250Ī¼g of Ampligen while two subjects will be enrolled in each cohort to receive placebo.

In the trial, the participants will be given intranasal Ampligen every other day for 13 days.

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The safety, tolerability and biological activity on repeatedly administering intranasal Ampligen will be evaluated in the study.

AIM ImmunoTech CEO Thomas Equels said: ā€œAIM is pleased with the positive results in this first cohort. This Phase I safety study is designed to test the parameters of Ampligenā€™s intranasal tolerance before commencing a Phase II study.

ā€œWhile the higher doses that we plan to test in this Phase I trial may or may not be well tolerated, we plan on moving quickly into Phase II studies with the doses that have successfully passed these Phase I tests, such as the dose used in Cohort 1.ā€

In a separate development, Intravacc has reported positive pre-clinical data for its SARS-CoV-2 Outer Membrane Vesicle (OMV) based recombinant Spike protein (rSp) candidate nose spray vaccine.

Data showed that 30% and 90% virus neutralising antibodies, respectively, were identified in the mice receiving the CovOMV- and CovOMV-click vaccines.