Humacyte, Inc. announced that it has submitted a Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.

The FDA has a 60-day review period to determine whether the BLA is complete and acceptable for filing. Humacyte has requested Priority Review of the application and, if granted, the review should be completed within six months of the filing acceptance date. In May 2023 the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for use of the HAV in urgent arterial repair following extremity vascular trauma.

In addition, the HAV was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA?s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel, such as traumatic injuries. The HAV, a bioengineered tissue, is under investigation as an infection-resistant, universally implantable conduit for use in vascular repair. Designed to be ready off-the-shelf, the HAV has the potential to save valuable time for surgeons and to improve outcomes and reduce complications for patients.

The HAV can be produced at commercial scale in Humacyte?s existing manufacturing facilities, which are expected to have the capacity to provide thousands of vessels for treating patients in need. 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 repair, 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.

Results from the V005 Phase 2/3 clinical trial and from the treatment of wartime injuries in Ukraine were most recently presented in November at the VEITHsymposium®, a major vascular surgery conference in New York City. The V005 trial is a single-arm study conducted in the U.S. and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events for whom the standard of care, saphenous vein, was not feasible or available for vascular repair. As a single-arm study, the comparators for the HAV results were systematic literature reviews and meta-analysis of studies evaluating synthetic grafts in vascular injury repair.

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 met its objectives, and the HAV demonstrated a higher 30-day secondary patency rate of 90.2% for the patients with extremity vascular trauma compared to 78.9% historically reported for synthetic grafts. Primary patency for the HAV was 84.3% for the patients with extremity vascular trauma, although no comparison to synthetic graft primary patency was possible since this measure was not reported in the benchmark publications.

The HAV also demonstrated lower amputation rates, with a rate of 9.8% for patients with extremity vascular trauma, compared to 24.3% historically reported for synthetic grafts. Furthermore, the HAV demonstrated lower rates of infection, with a rate of 2.0% for the V005 patients with extremity vascular trauma compared to 8.4% historically reported for synthetic grafts. The FDA has advised Humacyte to include in the BLA submission patient outcomes from a humanitarian program conducted in Ukraine.

The results for the 16 patients from Ukraine with extremity vascular trauma who provided consent for use of their results in the BLA filing are known as the V017 trial. A high success rate for patients in the V017 trial was observed, with a 30-day primary and secondary patency of 93.8%, zero amputations, and zero cases of infection of the HAV. An analysis of an integration of results from the V005 and V017 trials concluded that the HAV demonstrated higher patency with a 30-day secondary patency rate of 91.5% for patients with extremity vascular trauma compared to 78.9% historically reported for synthetic grafts.

For the secondary comparison of amputation rates, the HAV demonstrated an improvement, with a rate of 4.5% for integrated V005 and V017 results, compared to 24.3% historically reported for synthetic grafts. For the secondary comparison of infection, the HAV demonstrated an improvement, with a rate of 0.9% for integrated data as compared to 8.4% historically reported for synthetic grafts.