Humacyte has announced positive topline interim results for the V012 Phase 3 study of the acellular tissue engineered vessel (ATEV) in female patients for dialysis access. In a prespecified interim analysis conducted in the first 80 patients enrolled in the study, the V012 trial’s primary endpoint was met with the ATEV observed to have an average of 91 more catheter-free days compared to autologous arteriovenous (AV) fistula, the current standard of care.
In accordance with the study protocol, as a result of meeting the primary endpoint, study enrolment will terminate and existing patients will continue to be followed as per protocol. Humacyte plans to file a supplemental Biologics License Application (BLA) with the US Food and Drug Administration (FDA) during the second half of 2026. The currently planned target indication is focused on adult patients with end-stage kidney disease who are at increased risk of AV fistula maturation failure.
“We are excited to announce positive clinical results for the Phase 3 V012 study, particularly as these results represent a real advancement in the dialysis care for female patients, a population that currently has suboptimal access options,” said Shamik Parikh, Humacyte’s chief medical officer. “Patients receiving an ATEV had an average of three months additional catheter-free time as compared to AV fistula, a highly significant outcome. Reducing patients’ reliance on catheters is critical given the high risk of infection and complications seen with indwelling catheters. These results reinforce the potential of our bioengineered human blood vessel to improve outcomes while addressing longstanding challenges in dialysis access.”
The V012 clinical study is designed to demonstrate the efficacy and safety of the ATEV as a dialysis access method compared to autologous AV fistula in female dialysis patients, a high-unmet-need population. V012 is a Phase 3, prospective, multicentre, open-label, randomised, two-arm comparative study conducted in the USA in up to 150 patients, with 120 patients currently enrolled. The primary measure of efficacy is total days free from indwelling catheter—catheter-free days—until 365 days after access placement, or until access abandonment, whichever occurs first.
A prespecified interim analysis was conducted after the first 80 patients enrolled had completed 12 months of follow-up. In this analysis, patients implanted with the ATEV achieved an average of 220 catheter-free days compared to 129 catheter-free days for patients who received an AV fistula. The result was statistically significant (p=0.0007), meeting the primary endpoint of the study.
The primary safety measure in the V012 study is the number and severity of infections related to all accesses, including catheters, from the date of access creation until 365 days thereafter. Patients receiving the ATEV incurred infections at a rate of six per 100 patient years, as compared to 23 per 100 patient years for patients receiving an AV fistula procedure. There were no study access-associated infections reported in the ATEV patients, while there were three among the AV fistula patients. There were no spontaneous ruptures reported in either of the treatment groups. The overall benefit risk profile of the ATEV was observed to be favourable, with no new or unexpected safety signals identified.
According to Humacyte, the company’s ATEV is a bioengineered human tissue derived from cultured human cells that is designed to be a universally implantable vascular conduit for use in vascular replacement and repair. The ATEV has been observed to have a low rate of infection in multiple clinical trials. The ATEV is designed to be available off-the-shelf, and ready whenever surgeons need it, potentially saving valuable operating room time and improving patient outcomes.
Results from the V012 Phase 3 study were presented recently at the Society for Vascular Surgery’s (SVS) Vascular Annual Meeting (VAM; 10–13 June, Boston, USA) in the Women’s Health seminar.
Humacyte notes that, for uses other than the US FDA approval in the extremity vascular injury indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
