AIM ImmunoTech reports safety, tolerability, biological data for Ampligen

AIM ImmunoTech reported that data were recently presented by Lisanne C.A. Smidt – Centre for Human Drug Research, CHDR, Leiden, the Netherlands in a poster titled, "Safety, tolerability and biological activity of repeated intranasal administration of TLR3 agonist Ampligen in healthy subjects," at the British Society for Immunology Congress 2022 . The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen in healthy subjects. The study found: Repeated intranasal administration of Ampligen was well tolerated. No severe or serious AEs reported; Solicited local AEs were comparable across all treatment groups and placebo; An increase in IL-6, IL-8, and TNF production was observed for both Ampligen and placebo after dosing; MCP-1 and RANTES – which are important immunomodulators – peaked 3-24 hours after administration, mainly for 500 undefined Ampligen; At doses evaluated, intranasal Ampligen administration did not drive a significant change in nasal immune cell abundance. AIM Chief Executive Officer Thomas Equels stated: "The results from this Phase 1 study evaluating intranasal Ampligen in healthy subjects support the promising potential in the ability of Ampligen to inhibit respiratory viruses at the point of entry. The repeated intranasal dosing regimen was shown to be well tolerated in all tested dose levels. These Phase 1 data, in combination with the prior promising results of in vitro modelling which demonstrated that Ampligen could decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels, continue to be encouraging as we advance the development of Ampligen as a potential intranasal prophylactic approach to prevent infection and spread of COVID-19." In a randomized, double-blind, placebo-controlled, dose-escalation study, Ampligen or placebo was administered in both nostrils every other day, for a total of 7 consecutive doses. Safety and tolerability were monitored for 28 days after first dosing. Type I interferon, NFB-mediated cytokines and chemokines were measured. Mucosal immune cells were characterized using spectral flow cytometry.