AIM ImmunoTech is set to commence the Phase I clinical study of its Ampligen drug as an intranasal therapy for the treatment of Covid-19 and other respiratory viral diseases.
This forms a critical step in the company’s ongoing efforts to develop the drug as a potential prophylaxis or treatment for these diseases.
The latest development comes after the company received approval from the required Ethics Committee in the Netherlands.
AIM and the Centre for Human Drug Research (CHDR) had earlier entered a sponsorship agreement for the proposed AMP-COV-100 (CHDR2049) trial. The Dutch local Ethics Committee gave clearance last week to carry out this trial.
The current study intends to enrol a total of 40 healthy participants with eight each in each of the four Ampligen treatment groups and eight people receiving placebo.
It will evaluate the safety, tolerability and biological activity of repeated intranasal administration of Ampligen.
The participants will be given intranasal doses of the drug every other day for 13 days, for a total of seven doses each.
AIM CEO Thomas Equels said: “We are on track for site initiation later this month and expect to begin enrolling participants in the study during the first quarter of 2021.
“Importantly, our prior in vitro modelling at The Institute for Antiviral Research at Utah State University demonstrated that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage concentrations.”
AIM is focused on researching and developing therapeutics for treating various types of cancers, immune disorders and viral diseases, such as Covid-19.
Last month, the company dosed its first Covid-19 ‘long hauler’ patient in the active AMP-511 Expanded Access Program (EAP) with the Ampligen (rintatolimod) drug for the treatment of post-Covid-19 infection chronic fatigue-like symptoms.