Humacyte(US:HUMA) GlobeNewswire News Room·2024-10-28 11:00Core Insights - Humacyte, Inc. announced positive results from the V007 Phase 3 clinical trial of its acellular tissue engineered vessel (ATEV) for hemodialysis access, demonstrating superiority over the current standard of care, autogenous fistula, at six and twelve months [1][2][3] Clinical Trial Results - The ATEV showed functional patency rates of 81.3% at six months and 68.3% at twelve months, compared to 66.4% and 62.2% for the AV fistula, respectively [3][4] - The trial involved 242 hemodialysis patients, with a statistically significant joint test for superiority of ATEV versus AV fistula (p=0.0071) [3][4] - ATEV patients experienced a longer duration of hemodialysis over the first twelve months compared to AV fistula patients (p=0.0162) [3] Subgroup Analysis - In female patients (n=70), ATEV had significantly higher six-month and one-year patency rates compared to AV fistula (p<0.0001) and a longer duration of hemodialysis (8.3 months vs. 5.0 months, p=0.0011) [4] - In obese patients (n=93), ATEV also showed significantly higher patency rates and longer duration of hemodialysis (7.7 months vs. 4.5 months, p=0.0020) [4] - Diabetic patients (n=165) receiving ATEV had higher patency rates and longer duration of hemodialysis compared to AV fistula (7.4 months vs. 5.5 months, p=0.0155) [4] Safety Profile - Infection rates were low in both treatment arms, with 9.1% of ATEV patients experiencing access-related infections compared to 9.9% for AV fistula [5] - Treatment-Emergent Adverse Events (TAEEs) occurred in 98.3% of ATEV patients, with thrombosis being the most significant adverse event at 52.1% [5] Company Overview - Humacyte is focused on developing bioengineered human tissues and has a portfolio of ATEVs in late-stage clinical trials targeting various vascular applications [7] - The ATEV has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and is under review for a Biologics License Application for vascular trauma [7]