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Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma
-- Single-arm clinical trial was a success and showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic
About this update from Humacyte, Inc.
[{"type":"text","content":"-- Single-arm clinical trial was a success and showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks -- -- BLA planned to be filed with FDA in 4th Quarter 2023 -- -- Conference call and live webcast with Key Opinion Leaders at 8:00 a.m. ET today - DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. The single-arm clinical trial was a success and showed that the HAV in this study had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the Food and Drug Administration (FDA) during the 4th quarter of 2023. The V005 trial was a single-arm study conducted in the United States and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events. Patients enrolled in the study did not have the standard of care, saphenous vein, available to use as a bypass graft. As a result, had the patients not received the HAV, they likely would have been treated with synthetic grafts, ligation of the bleeding artery, and/or amputation. Trauma injuries are commonly contaminated, and therefore patients are at a high risk of infection. As a single-arm study, the comparators for the HAV results were benchmark outcomes for treatment with synthetics grafts based on a systematic literature search. The principal means of evaluation was comparability of secondary patency (blood flow) at 30 days, with primary patency (blood flow without intervention) also evaluated. Secondary comparisons comprised of improvement in rates of amputation and rates of infection at 30 days. A total of 69 patients were enrolled in the V005 trial, of which 51 had vascular injury of the extremities and comprised the primary evaluation group for the study. The V005 trial was a success, and the principal comparison of 30-day secondary patency for the HAV in the clinical trial was 90.2% for t...