Vasomune concludes Phase 1 trial of AV-001 to treat COVID-19 patients

Vasomune Therapeutics, Inc., a Toronto-based clinical-stage company which focuses on developing advanced therapeutics for the treatment of diseases linked with vascular dysfunction, has reportedly announced positive Phase 1 clinical study results for AV-001, a first-in-class injectable Tie2 receptor agonist.  

Notably, the company is planning on commencing the Phase 2a proof-of-concept study after review with FDA to assess the efficacy and safety of patients suffering from the novel coronavirus disease. 

In addition to the above, results from the study will support the development of AV-001 to Phase 2a clinical study in patients diagnosed with COVID-19 infection. Vasomune is co-developing AV-001 along with ANGes, Inc. and will file a Clinical Trial Application for AV-001 with Health Canada.

According to Dr. Leela Vrishabhendra, Principal Investigator of the trial, the administration of single doses of AV-001 was safe and tolerated in studied healthy candidates. These findings support constant development of AV-001 in patients with coronavirus patients, she added.

It must be noted that the Phase 1 randomized, placebo-controlled, double-blind trial of 48 healthy candidates, between the age of 20 to 63, was developed to understand the safety, pharmacokinetics, and tolerability of AV-001 after the administration of single-ascending and multiple- ascending doses of nearly 56 µg/kg per day for the entire week.

During this study, AV-001 was well-tolerated and safe and there were no discontinuations with regards to study medication, adverse events of special interest, clinically significant abnormal laboratory values.

For the record, the pharmacokinetics of AV-001 has proven to be consistent across dose groups and even after multiple injections, hence offering a broad safety margin over established threshold levels.

As per reports, Vasomune Therapeutics aims at reviewing the data with the U.S. FDA before initiating the Phase 2a proof-of-concept study to analyze the efficacy and reliability in patients with severe coronavirus infection.

Source Credit: https://www.businesswire.com/news/home/20210325005213/en/Vasomune-Announces-Preliminary-Positive-Phase-1-Clinical-Trial-Results-for-Vascular-Normalization-Therapy