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.
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By GlobalDataFurthermore, 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.
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.
