AIM ImmunoTech Inc (NYSEAMERICAN:AIM) said it has completed dosing of Cohort 2 in a Phase 1 clinical study to assess the safety, tolerability, and biological activity of Ampligen as an intranasal therapy, reporting no serious adverse events (SAE).
The company, which also reported no SAEs in Cohort 1, said the study will proceed with enrollment into Cohort 3.
The clinical study is crucial for its ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for coronavirus (COVID-19) and other respiratory viral diseases, the company added in a statement.
READ: AIM ImmunoTech headed in 2021 with $54.4M in capital as it advances Ampligen to treat COVID-19 and cancer
The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study AMP-COV-100. AIM ImmunoTech is sponsoring and funding the clinical study.
The company said the study protocol calls for a total of 40 healthy subjects to receive repeated administration of either Ampligen or a placebo. Subjects in Cohort 1 received 75 micrograms (μg) of Ampligen, while subjects in Cohort 2 received 200 μg of Ampligen.
The dosage will escalate to 500 μg in the next cohort, Cohort 3, with the highest level of 1250 μg planned for Cohort 4.
Florida-based AIM ImmunoTech said it will continue to provide interim updates on the clinical trial.
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