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Vasomune and AnGes Receive Favorable Recommendation from IDSMB for AV-001 (AV001-004) Phase 2a Study

Wednesday, November 15, 2023

Vasomune Therapeutics, Inc., a biopharmaceutical company in the clinical stage, has reported positive feedback from the Independent Data and Safety Monitoring Board (IDSMB) regarding their lead drug candidate, AV-001. The IDSMB's recommendation is for the continuation of the AV001-004 Phase 2a Study, which is focused on assessing AV-001's efficacy, safety, and tolerability in treating Acute Respiratory Distress Syndrome (ARDS) ( Identifier: NCT05123755).

Dr. Brian E. Jahns, the President and Chief Operating Officer, expressed satisfaction with the IDSMB's endorsement of the Phase 2a trial. He highlighted the company's belief in AV-001's potential to significantly improve outcomes for ARDS patients by restoring Tie2 signaling, promoting endothelial stability, reinforcing barrier defense, and preventing vascular leakage. The Phase 2a trial, AV001-004, symbolizes collaborative efforts with investigators, supported by grants from the US Department of Defense.

Ei Yamada, President & CEO of AnGes, emphasized the importance of the clinical study's data in informing ARDS treatment and anticipated an expedited clinical development of AV-001 following this pivotal milestone.

AV-001, originally discovered and designed at Sunnybrook Research Institute in Toronto, is being developed through a co-development agreement with AnGes, Inc. (TYO: 4563). This novel investigational medicine targets the Tie2 receptor, a transmembrane protein highly expressed on endothelial cells in the vasculature. AV-001 activates the nonredundant Tie2-Angiopoietin signaling axis, normalizing the vasculature by enhancing endothelial cell stability, restoring barrier defense, and preventing vascular leakage through stimulation of downstream pathways.

The therapeutic potential of AV-001 extends to various conditions associated with vascular dysfunction, including COVID-19, influenza, bacterial sepsis, acute kidney injury, glaucoma, hemorrhagic shock, sepsis, stroke, and diabetes-related complications. Pre-clinical studies have demonstrated AV-001's ability to tighten endothelial cell-cell junctions, promote endothelial cell survival, reduce pulmonary edema, and improve lung function, leading to significantly enhanced survival rates compared to untreated controls.



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