Clinical-stage biopharma firm Vasomune Therapeutics has dosed the first subjects in a Phase I study of its potential vascular normalisation Covid-19 therapy, AV-001, in healthy participants.
AV-001 targets the Tie2 tyrosine kinase receptor, a regulatory protein in the vasculature which maintains normal vascular function.
AV-001 has been originally discovered and designed at Sunnybrook Hospital in Toronto and is being developed by Vasomune Therapeutics along with AnGes.
The randomised, double-blind, placebo-controlled single and multiple ascending dose trial of AV-001 will evaluate the safety, tolerability and pharmacokinetics of a daily administration of single and multiple doses of AV-001.
Vasomune noted that if the benefit shown in animal studies translate to the clinic, the treatment can potentially improve survival and cut down hospitalisation duration of Covid-19 patients.
If the Phase I results demonstrate that AV-001 is safe and well-tolerated, the company will begin a Phase II proof-of-concept study to evaluate the efficacy in patients with moderate-to-severe Covid-19 disease.
Vasomune Therapeutics intends to submit an application to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) for AV-001 on successfully completing clinical trials for treating patients with moderate-to-severe Covid-19.
In preclinical studies involving a lethal RNA virus infection animal model of influenza/ARDS, AV-001 demonstrated stabilising the vasculature by improving endothelial cell stability, restoring normal barrier defence and hindering vascular leak.
Furthermore, the monotherapy improved survival and lung function versus the untreated controls.
AV-001 is being developed for the treatment of moderate-to-severe Covid-19 and acute respiratory distress syndrome (ARDS).
Estimates show that SARS-CoV-2 infects pulmonary endothelial cells and causes microvascular leaks, leading to initiation and propagation of respiratory distress and ARDS in Covid-19 patients.