Humacyte, Inc. (Nasdaq: HUMA) has announced positive results from its V007 Phase 3 clinical trial evaluating the acellular tissue engineered vessel (ATEV) for arteriovenous (AV) access in patients with end-stage renal disease undergoing hemodialysis. The study, presented at the American Society of Nephrology's Kidney Week 2024, demonstrated the ATEV's superior performance compared to the current standard of care, autogenous fistula, particularly in high-risk patient populations.
ATEV Outperforms Standard Fistula in Key Metrics
The V007 Phase 3 trial, a prospective, multi-center, randomized study, enrolled 242 hemodialysis patients in the United States. Participants were randomized to receive either the ATEV or an AV fistula for hemodialysis access and followed for up to 24 months. The co-primary endpoints were functional patency at six months and secondary patency at 12 months.
At six months, 81.3% of patients implanted with the ATEV exhibited functional patency, compared to 66.4% of those receiving an AV fistula. At 12 months, secondary patency was observed in 68.3% of ATEV recipients versus 62.2% in the AV fistula group. The joint test for superiority of the ATEV versus AV fistula at six and 12 months was statistically significant (p=0.0071).
Significant Improvements in High-Risk Subgroups
Subgroup analysis revealed notable benefits of ATEV in patient populations that typically experience poorer outcomes with AV fistulas. Female patients receiving ATEV achieved a significantly longer duration of hemodialysis over the first 12 months compared to those receiving AV fistula (8.3 months vs 5.0 months, p=0.0011). Similar improvements were observed in obese patients (7.7 months vs 4.5 months, p=0.0020) and diabetic patients (7.4 months vs 5.5 months, p=0.0155).
"These results show that availability of the ATEV, a biologic conduit, could be game changing in improving arteriovenous access in many hemodialysis patients," said Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the Center for Surgery and Public Health, and Assistant Professor of Surgery at Harvard Medical School. "I was particularly pleased to see positive results in female, obese, and diabetic patients, groups which typically have poor outcomes with autogenous fistula procedures and historically limited treatment alternatives for hemodialysis access."
Safety Profile and Thrombosis Management
While infection rates were similar between the two groups (9.1% for ATEV vs 9.9% for AV fistula), the ATEV group experienced a higher rate of thrombosis (52.1% vs 9.1%). However, 94% of ATEV patients with thrombosis were successfully treated.
Implications for Hemodialysis Access
The ATEV represents a potentially significant advancement in hemodialysis access, particularly for patients at high risk of AV fistula failure. The superior patency rates and improved dialysis duration observed in the Phase 3 trial suggest that ATEV could become a valuable alternative to autogenous fistulas. Humacyte is now well-positioned to pursue FDA approval for ATEV, with the potential to transform the treatment landscape for hemodialysis patients.
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
