AIM ImmunoTech Inc (NYSE:AIM) (NYSE:AIM) reported that a Phase 1 clinical study of Ampligen as an intranasal treatment for coronavirus (COVID-19) had shown "no severe adverse events" and that the drug was "generally well tolerated".
The trial saw 40 healthy subjects receive either Ampligen or a placebo, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms.
More details of the safety report are now being published on both the AIM website and on the website for the Centre for Human Drug Research (CHDR), the biotech noted.
And based on these positive safety results, AIM ImmunoTech said it had moved forward to develop Ampligen as a potential intranasal treatment for COVID-19 with the following:
- A Phase 2a Human Challenge Trial (HCT) to test Ampligen as a potential intranasal prophylactic using a human rhinovirus (HRV-16, a common cold virus) and influenza A virus (H3N2), which could help establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies, as well as mutations of known viruses such as SARS-CoV-2, which causes COVID-19
- A pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for two separate Phase 2 clinical studies to study the potential of Ampligen as both an intranasal and an infusion treatment for early-onset COVID-19
- The filing of a provisional patent application for Ampligen as a potential early-onset intranasal therapy designed to enhance and expand infection-induced immunity, epitope spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses
The immuno-pharma company is also focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases.
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