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Vasomune Therapeutics has reported preliminary positive top-line data from the Phase I clinical trial of vascular normalisation therapy in healthy volunteers.

AV-001 is a first-in-class, injectable Tie2 receptor agonist originally discovered and designed at Sunnybrook Hospital in Toronto, Canada. It is currently developed by Vasomune Therapeutics under a co-development agreement with AnGes.

The randomised, double-blind, placebo-controlled study enrolled a total of 48 healthy subjects aged 20 to 63 years.

It analysed the safety, tolerability and pharmacokinetics of AV-001 following administration of single-ascending and multiple-ascending doses up to 56µg/kg a day for seven consecutive days.

Data showed that AV-001 was safe and well-tolerated with no discontinuations relating to study medication, serious adverse events (SAEs), severe adverse events (AEs), adverse events of special interest (AESI), clinically significant abnormal laboratory values, or abnormal ECGs.

Furthermore, AV-001’s pharmacokinetics was similar across dose groups and after single and multiple injections, thereby offering a wide safety margin over established threshold levels.

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Vasomune Therapeutics intends to conduct a review of the data with the US Food and Drug Administration (FDA) before commencing a Phase IIa exploratory proof-of-concept study to evaluate the safety and efficacy in patients with severe Covid-19 disease.

Principal investigator of the study Dr Leela Vrishabhendra said: “Administration of single and multiple doses of AV-001 was safe and well-tolerated in the studied normal healthy volunteers.

“These findings are encouraging and support the continued development of AV-001 in patients with Covid-19 disease.”

In preclinical studies of a lethal RNA virus infection animal model of influenza, AV-001 stabilised the vasculature by improving endothelial cell stability, restoring normal barrier defence and hindering vascular leak.

In addition, the AV-001 monotherapy significantly enhanced survival and lung function versus untreated controls and demonstrated the benefit of better recovery along with antiviral therapy.