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Humacyte's Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) for Vascular Trauma Repair Reaches Full Enrollment

Thursday, July 27, 2023

Humacyte, a clinical-stage biotechnology platform company (Nasdaq: HUMA), has achieved full enrollment in its Phase 2/3 vascular trauma trial (V005). The trial aims to support a Biologics License Application (BLA) filing for the company's Human Acellular Vessel™ (HAV™) product, designed to provide a bioengineered human artery that can repopulate with the patient's cells, offering a durable and infection-resistant solution for damaged and diseased arteries. The HAV™ has the potential to be life and limb-saving, especially in challenging scenarios. The trial is a pivotal study conducted at Level 1 Trauma Centers in the U.S. and Israel, focusing on patients with vascular trauma injuries. The results from the trial are expected to support the BLA filing planned for the fourth quarter of 2023.

The HAV™ offers several advantages over traditional treatments for vascular trauma. It can be used immediately without the need for vein harvesting, which is often associated with complications and pain. The off-the-shelf availability of HAV™ can potentially save valuable time in critical situations. Additionally, the HAV™ is made from the same tissue as natural human vessels, making it highly infection-resistant, thus suitable for treating contaminated wounds resulting from major traumatic injuries.

The V005 trial, a single-arm, open-label study, will assess the HAV™ patency in patients with vascular trauma of the extremity compared to historical benchmarks. The company anticipates reporting top-line results from the trial before the end of the third quarter of 2023.

Dr. Laura Niklason, CEO of Humacyte, is optimistic about the potential of HAV™ to revolutionize vascular injury treatments, not only in civilian settings but also in more challenging environments like the battlefield. She highlights that the completion of target enrollment in the V005 trial is a significant milestone in advancing their groundbreaking science and providing new treatment options for patients facing life or limb loss where current therapies are insufficient.

It is worth noting that the HAV™ is investigational and has not received approval for sale from the FDA or any other regulatory agency. Humacyte's HAV™ has accumulated more than 1,000 patient-years of experience worldwide through clinical trials in various indications, including vascular trauma, arteriovenous access for hemodialysis, and peripheral artery disease. Additionally, the company is also running a humanitarian aid program in Ukraine, where the HAV™ has been successfully used to treat vascular trauma patients in the ongoing war. Data from this program will also be included in the BLA filing with the FDA.

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