TORONTO, CANADA | March 24, 2026
A significant milestone has been reached in clinical-stage biopharmaceutical research as the first patient has been dosed in a novel clinical study evaluating Pegevongitide (AV-001), an innovative drug candidate designed to prevent acute ischemic brain injury in hemodialysis patients. Developed by Vasomune Therapeutics, Inc. in collaboration with AnGes, Inc., this made-in-Canada therapeutic targets the growing clinical challenge of cerebrovascular instability associated with routine dialysis, a condition linked to vascular cognitive impairment in up to 70% of patients undergoing treatment.
Novel Mechanism Targets Cerebrovascular Stability
The investigational drug Pegevongitide (AV-001) is designed to stabilize the cerebral vasculature during the hemodialysis process, where patients are exposed to repeated circulatory stress that can lead to ischemic brain injury and long-term neurological damage. The therapy works by activating the Tie2/Angiopoietin-1 signaling pathway, a critical regulator of vascular integrity, helping to reduce vascular leakage and maintain blood vessel stability.
This targeted mechanism represents a new therapeutic approach in nephrology and neurology, aiming not only to prevent acute injury but also to preserve cognitive function and brain health in a highly vulnerable patient population. The ability to address both vascular and neurological complications positions AV-001 as a potential first-in-class intervention in this space.
Addressing High Unmet Need in Hemodialysis Care
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Patients undergoing chronic hemodialysis are at increased risk of recurrent ischemic insults to the brain, driven by fluctuations in blood pressure and reduced cerebral perfusion during treatment sessions. These repeated injuries contribute to cognitive decline, reduced quality of life, and increased morbidity, making it a critical area of unmet medical need.
The ongoing study, led by Dr. Christopher McIntyre, a leading expert in nephrology and dialysis research, focuses on evaluating the safety and efficacy of AV-001 in mitigating these risks. By targeting the underlying vascular dysfunction, this therapy could significantly improve outcomes for patients who currently have limited options for protecting neurological health during dialysis.
Advancing Clinical Innovation in Vascular Therapeutics
The initiation of this study marks a key advancement for Vasomune Therapeutics, a company specializing in vascular normalization therapies aimed at addressing diseases linked to vascular leak and endothelial dysfunction. The company’s lead candidate, AV-001, has been developed through a bench-to-bedside approach, reflecting years of translational research in vascular biology. In parallel, AnGes, Inc.
brings expertise in gene-based and vascular-targeted therapies, strengthening the development pathway for this innovative drug. Positive results from this early-stage trial are expected to support larger confirmatory studies, paving the way for potential regulatory approval and broader clinical adoption.
This first patient dosing represents a critical step forward in developing a transformative therapy that could redefine the standard of care for hemodialysis patients, offering a proactive solution to prevent brain injury and improve long-term neurological outcomes.
Source: Vasomune Therapeutics press release
