Clinical TrialJun 10, 2026, 04:03 PM
Humacyte ATEV Phase 3 Meets Primary Endpoint; BLA H2 2026
AI Summary
Humacyte announced positive top-line interim results from its V012 Phase 3 study for the acellular tissue engineered vessel (ATEV) in female dialysis patients. The ATEV met its primary endpoint, demonstrating significantly more catheter-free days compared to the standard of care, autologous AV fistula. The company plans to file a supplemental Biologic License Application with the FDA in the second half of 2026. The ATEV also showed a favorable safety profile with a lower infection rate.
Key Highlights
- ATEV met V012 Phase 3 primary endpoint with superior catheter-free days (p=0.00070).
- ATEV patients achieved an average of 220 catheter-free days vs. 129 for AV fistula patients.
- This represents 91 more catheter-free days for ATEV patients.
- Study enrollment will terminate after 80 patients due to meeting the primary endpoint.
- Humacyte plans to file a supplemental BLA with the FDA in H2 2026.
- ATEV patients incurred infections at 6 per 100 patient years vs. 23 for AV fistula patients.
- No study access-associated infections reported in ATEV patients; three in AV fistula patients.
Price Impact
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