Humacyte ATEV outperforms standard of care
- Humacyte (NASDAQ:HUMA) reported positive Phase 3 V012 results for its bioengineered blood vessel (ATEV), which demonstrated superiority over autologous arteriovenous (AV) fistulas for women on dialysis.
- The trial met its primary superiority endpoint with ATEV patients averaging 220 catheter-free days versus 129 days for the standard-of-care group.
- Following the positive interim analysis, the company plans to file a supplemental Biologics License Application (sBLA) with the FDA in the second half of 2026.
Humacyte (NASDAQ:HUMA) announced that its Phase 3 V012 study met its primary superiority endpoint, showing the company’s acellular tissue engineered vessel (ATEV) significantly reduces time spent on dialysis catheters.
In the prespecified interim analysis, women receiving the ATEV experienced an average of 220 catheter-free days in the first year, compared to 129 days for those treated with the traditional AV fistula.
"This study shows that our bioengineered blood vessel can keep patients off catheters longer than the current standard of care, with fewer infections," said Humacyte CEO Dr. Laura Niklason.
The study recorded a significantly lower infection rate for the ATEV group, at approximately 6 per 100 patient-years, compared to 23 per 100 patient-years for the AV fistula cohort.
Following the success of this interim analysis, Humacyte stated that enrollment will terminate at 120 patients per study protocol, and the company intends to use the data to support a supplemental BLA filing later this year.
The company is targeting the indication for adult patients with end-stage kidney disease who are at high risk of AV fistula maturation failure.
Following the announcement, the Humacyte share price was $1.08.
