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.
AIM is developing Ampligen as potential Covid-19 prophylaxis or treatment as well as for other respiratory viral diseases.
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’, 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 75μg, 200μg, 500μg and 1250μg 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.
The safety, tolerability and biological activity on repeatedly administering intranasal Ampligen will be evaluated in the study.
AIM ImmunoTech CEO Thomas Equels said: “AIM is pleased with the positive results in this first cohort. This Phase I safety study is designed to test the parameters of Ampligen’s intranasal tolerance before commencing a Phase II study.
“While 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.”
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.