Pharma Focus America

Vasomune Therapeutics Granted Fast Track Designation by US FDA for AV-001, a Novel Investigational Medicine

Wednesday, May 29, 2024

Vasomune Therapeutics, Inc., has just announced a significant development: the US Food and Drug Administration (FDA) has granted Fast Track designation for AV-001. This drug is being investigated for its potential in preventing or treating moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) in hospitalized patients with viral and/or bacterial respiratory infections. AV-001 is a pioneering synthetic PEGylated peptide designed to target the Tie2 receptor, which plays a crucial role in maintaining vascular stability and endothelial function, particularly within the pulmonary system.

The Fast Track designation is an important regulatory milestone, indicating the potential of AV-001 to address a critical medical need in ARDS. This syndrome is a global health challenge with high mortality rates, especially in severe cases, which can reach up to 46%. Phase 1 data have shown that AV-001 is safe, with favorable pharmacokinetics for once-daily dosing, and it effectively activates the Tie2 receptor, demonstrating its potential efficacy. AV-001 is currently undergoing Phase 2a clinical trials for ARDS prevention and treatment in pneumonia patients, with active recruitment underway, in collaboration with AnGes Inc.

Vasomune, emphasized the company's dedication to addressing persistent medical challenges, particularly in ARDS and diseases related to vascular endothelial instability. He expressed gratitude for the support received from various sources, including the United States Department of Defense Congressionally Directed Medical Research Programs and the National Research Council of Canada Industrial Research Assistance Program.

AnGes, expressed optimism about the FDA's support for expedited development, seeing it as a crucial step forward in their efforts to redefine treatment approaches with AV-001. He looks forward to the ongoing Phase 2a study, AV001-004.

Originally developed at Sunnybrook Research Institute in Toronto, AV-001 is a joint venture between Vasomune Therapeutics, Inc. and AnGes, Inc. (TYO: 4563). This novel drug targets the Tie2 receptor, crucial for endothelial function in the vasculature. By activating the Tie2-Angiopoietin signaling axis, AV-001 restores vascular integrity, enhances endothelial stability, and prevents vascular leakage. Pre-clinical studies have shown promising results, indicating AV-001's potential to improve survival rates by reducing pulmonary edema and enhancing lung function.



Thermo Fisher Scientific - mRNA ServicesFuture Labs Live USA 2024World Vaccine Congress Europe 2024World Orphan Drug Congress 2024Advanced Therapies USA 2024World Orphan Drug Congress Europe 2024