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March 26, 2021updated 12 Jul 2022 11:21am

Vasomune reports positive data from vascular normalisation therapy trial

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

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

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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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.

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.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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