Humacyte Completes Enrollment in Phase 2/3 Trial of Human Acellular Vessel for Vascular Trauma Repair

July 26, 2023—Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues, announced the completion of enrollment of V005, its phase 2/3 vascular trauma trial. Results from the trial are expected to support a biologics license application (BLA) filing for Humacyte’s Human Acellular Vessel (HAV) in vascular trauma repair that is planned for the fourth quarter of 2023.

According to the company, HAV is a regenerative medicine product candidate designed to provide surgeons with an off-the-shelf bioengineered human artery. HAV has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries.

Humacyte stated that the V005 trial is a single-arm, open-label, pivotal study of patients with vascular trauma injuries that is being conducted at level 1 trauma centers in the United States and Israel. The primary efficacy assessment will be based on 30-day HAV patency in patients who have vascular trauma of the extremity, as compared to historic benchmarks reported in the literature.

At the time of V005 target enrollment, a total of 68 patients had received the HAV in the V005 trial. Of these patients, 51 had vascular trauma of the extremity and compose the primary efficacy analysis.

The company, 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 of 2023.

In May 2023, Humacyte received the FDA’s Regenerative Medicine Advanced Therapy designation for the HAV in vascular trauma. The company stated that the designation allows for close collaboration of the company with the FDA and increases the chance for a priority review of a BLA after it is filed.

The V005 study is intended to support Humacyte’s BLA filing with the FDA for treatment of extremity vascular trauma when a synthetic graft is not indicated and when an autologous vein is not feasible.

In addition to the V005 trial, the HAV is also being used in Ukraine under a humanitarian aid program that has treated 19 vascular trauma patients in the ongoing war, demonstrating a high rate of favorable outcomes in treating some of the most difficult and infection-prone vascular injuries. The company noted that the data from the Ukraine humanitarian program will be included in the BLA filing with the FDA.

The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency, advised Humacyte.

In September 2022, Humacyte announced that a clinical update on the HAV for treatment of vascular trauma was presented by Todd E. Rasmussen, MD, (Colonel [Retired], United States Air Force), at the 44th International Committee of Military Medicine World Congress held in Brussels, Belgium. The HAV received priority designation for the treatment of vascular trauma by the United States Secretary of Defense, noted the company.

The HAV has accumulated > 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. Humacyte’s portfolio of HAVs is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis (V007, enrollment completion annnounced in April 2023), and peripheral arterial disease (6-year phase 2 trial outcomes announced in January 2023). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications.