Vasomune and AnGes Announce First Patient Enrolled in Phase 2a Clinical Study Evaluating AV-001 for the Treatment of Severe COVID-19 Disease

TORONTO--(BUSINESS WIRE)-- Vasomune Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of diseases associated with vascular dysfunction, announced today it has dosed the first patient in the Phase 2a clinical study to evaluate AV-001 in patients hospitalized with severe COVID-19 disease. AV-001 is a novel pegylated peptide targeting the Tie2 receptor designed to activate the angiopoietin/Tie2 signaling pathway to normalize the vasculature.

“First patient dosing is an important step for Vasomune and our co-development partner AnGes in our efforts to potentially provide physicians and patients with a novel therapeutic option to treat severe COVID-19 disease, including the emergence of new variants,” said Douglas A. Hamilton, President and CEO of Vasomune. “We believe outcomes for patients with severe COVID-19 disease can be significantly improved through restoration of Tie2 signaling to promote endothelial stability, enhance barrier defense and block vascular leak.”

Approximately 120 patients hospitalized with severe COVID-19 disease will be enrolled in this randomized, double-blind, placebo-controlled multiple ascending dose Phase 2a clinical study evaluating 12.5, 25 and 56 µg/kg/day of AV-001 compared with placebo together with standard of care (details can be found at www.ClinicalTrials.gov using the identifier NCT05123755). The clinical study will be conducted in approximately 15 sites in the United States, followed by South America.

About AV-001

Originally discovered and designed at Sunnybrook Research Institute at Sunnybrook Hospital in Toronto, AV-001 is being developed by Vasomune Therapeutics, Inc. under a co-development agreement with AnGes, Inc. [TYO: 4563]. AV-001 is a novel investigational medicine that targets the Tie2 receptor, a transmembrane protein target most highly expressed on the surface of endothelial cells in the vasculature. AV-001 activates the nonredundant Tie2-Angiopoietin signaling axis, and through stimulation of multiple downstream pathways restores normal vascular function and endothelial stability. Vascular dysfunction contributes to the underlying disease pathophysiology in patients with COVID-19, including respiratory distress, hypercoagulopathy, viral sepsis, myocardial inflammation and acute kidney injury, especially in those patients with pre-existing vascular comorbidities, such as hypertension, diabetes and obesity. Emerging evidence suggests SARS-CoV-2 infects pulmonary endothelial cells and causes microvascular leaks, contributing to the initiation and propagation of respiratory distress in COVID-19 patients by altering blood vessel barrier integrity, promoting a coagulated state and inducing vascular inflammation (endotheliitis). In preclinical studies involving a lethal RNA virus infection animal model of influenza, AV-001 has been shown to stabilize the vasculature by enhancing endothelial cell stability, restoring normal barrier defense and blocking vascular leak. Importantly, AV-001 monotherapy significantly improved survival and lung function compared to untreated controls and showed the benefit of enhanced recovery in combination with antiviral therapy.

About Vasomune Therapeutics, Inc.

Vasomune Therapeutics, Inc. is a private clinical-stage biopharmaceutical company developing the next generation of medicines to harness the body’s ability to defend against illness. Originally founded in 2014, Vasomune discovers and develops drugs using a novel therapeutic approach focused on vascular normalization strategies. Vascular dysfunction is associated with the pathology of several disease states, including COVID-19, viral and bacterial-associated pneumonia, acute kidney injury, glaucoma, hemorrhagic shock, sepsis, stroke and complications associated with diabetes. Vasomune’s corporate headquarters and laboratories are located in Toronto, Canada with US offices in San Mateo, CA. For more information about the company and its product candidates, please visit www.vasomune.com.

About AnGes, Inc.

AnGes, Inc., a biopharmaceutical company founded in December 1999, focuses on the development of gene-based medicines. In March 2019, AnGes obtained conditional and time-limited approval for its lead product, Collategene® (Hepatocyte Growth Factor; HGF—plasmid gene therapy), for the treatment of lower limb ischemic ulcers. In September 2019, AnGes commenced commercialization in Japan of Collategene®, the world’s first marketed drug using plasmid DNA. AnGes is currently working on the development of DNA vaccines for COVID-19 and hypertension, a Tie2 tyrosine kinase receptor agonist (AV-001) for COVID-19 treatment and an NF-κB decoy oligonucleotide for chronic discogenic lumbar back pain. Furthermore, AnGes acquired EmendoBio in December 2020 to expand its capabilities in genome-editing technologies. For more information, visit https://www.anges.co.jp/en/.

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