Humacyte today announced completion of enrolment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company’s Human Acellular Vessel (HAV) in vascular trauma repair.
A press release details that the HAV 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 II/III vascular trauma trial are intended to support a BLA filing with the US 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 I trauma centres in the USA 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 revolutionise 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 Laura Niklason, CEO of Humacyte. “The completion of the target enrolment in Humacyte’s Phase II/III 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 therapies—with the potential to provide treatment options for patients facing loss of life or limb for whom current therapies are either inadequate or not available.”
Humacyte’s HAV is a universally implantable, bioengineered human artery that is designed to overcome the challenges associated with traumatic injuries, the company states. It is available to the surgeon immediately, and eliminates the need to harvest and repurpose a vein. Because it is available off the shelf, the HAV can ultimately save valuable time and potentially reduce complications like amputations and tissue loss. Because the HAV is comprised of the same tissue that makes up natural human vessels, it has the potential to repopulate with the patient’s own cells. Clinical results suggest that the HAV is highly infection resistant and therefore is well suited for treating the contaminated wounds created by major traumatic injuries. Importantly, the HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, providing thousands of vessels for treating injured patients.
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. The completion of V005 enrolment comes on the heels of Humacyte receiving the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for the HAV in vascular trauma in May 2023. The RMAT designation allows for close collaboration between Humacyte and the FDA, and increases the chance for a priority review of a BLA after it is filed. At the time of V005 target enrolment, a total of 68 patients had received the HAV in the V005 trial, of which 51 had vascular trauma of the extremity and comprise the primary efficacy analysis.
In addition to the V005 trial, Humacyte notes that the HAV is also being used in Ukraine under a humanitarian aid programme that has treated 19 vascular trauma patients in the ongoing war, demonstrating a high rate of favourable outcomes in treating some of the most difficult and infection-prone vascular injuries. The data from the Ukraine humanitarian program will be included in the BLA filing with the FDA. The HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma, arteriovenous access for haemodialysis, and peripheral arterial disease.
Humacyte advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.