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Humacyte Completes Enrollment in Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) for Vascular Trauma Repair
-Top-line results planned to be released in third quarter 2023- -Trial results are intended to support Biologics License Application (BLA) planned for fourth
About this update from Humacyte, Inc.
[{"type":"text","content":"-Top-line results planned to be released in third quarter 2023- -Trial results are intended to support Biologics License Application (BLA) planned for fourth quarter 2023- DURHAM, N.C., July 26, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced completion of enrollment of its Phase 2/3 vascular trauma trial (V005) that is expected to support a BLA filing for Humacyte’s HAV in vascular trauma repair. The HAV, an innovative regenerative medicine product candidate, is designed to provide surgeons with an off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries. The HAV has the potential to assist healthcare professionals in saving life and limb in some of the most difficult circumstances. The results from the Phase 2/3 vascular trauma trial are intended to support a BLA filing with the Food and Drug Administration (FDA), planned for the fourth quarter 2023. The V005 trial is a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level 1 Trauma Centers in the U.S. and Israel. The primary efficacy assessment will be based on a 30-day HAV patency (presence of blood flow) in patients who have vascular trauma of the extremity, as compared to historic benchmarks reported in literature. Humacyte, the clinical trial sites, and contracted service providers are preparing for locking of the trial database in order to report the V005 results. The Company currently expects to complete these activities and report top-line results from the trial before the end of the third quarter 2023. “We believe that the HAV could revolutionize the ability of surgeons to save the lives and limbs of patients suffering vascular injuries, not only in civilian settings, but also in more challenging environments like the battlefield,” said Dr. Laura Niklason, CEO of Humacyte. “The completion of the target enrollment in Humacyte’s Phase 2/3 vascular trauma trial is expected to enable BLA submission, and is another important landmark moment for our groundbreaking science. Our regenerative medicine technologies create dramatic new...