Humacyte, Inc. 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, 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. Treating traumatic injuries, such as those occurring with car accidents or gunshot wounds, can be especially challenging due to the severity of the injury, the risk of infection, and the need to treat the patient quickly to avoid loss of life or limb. Under current practices, surgeons often harvest a vein from the patient?s leg, which requires additional time and expert training for the surgeon. The incision, pain, and wound complications associated with cutting into the leg to remove a vein also cause difficulties for patients and caregivers. Current off-the-shelf alternatives to veins, such as plastic vessel grafts, are highly prone to infection and so are not used very often for treating trauma patients. Humacyte?s HAV is a universally implantable, bioengineered human artery that is designed to overcome these challenges. It is available to the surgeon immediately, and eliminates the need to harvest and repurpose a vein. Because it is 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 enrollment comes on the heels of Humacyte receiving the FDA's Regenerative Medicine Advanced Therapy 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 enrollment, 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, 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 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 hemodialysis, and peripheral artery disease.
The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.