DM Healthcare Investment

Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel™ (HAV™) in treatment of patients with vascular trauma

September 12, 2023

• Single-arm clinical trial was a success and showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks
• BLA planned to be filed with FDA in 4th Quarter 2023
• Conference call and live webcast with Key Opinion Leaders at 8:00 a.m. ET today

The V005 trial was a single-arm study conducted in the United States and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events. Patients enrolled in the study did not have the standard of care, saphenous vein, available to use as a bypass graft. As a result, had the patients not received the HAV, they likely would have been treated with synthetic grafts, ligation of the bleeding artery, and/or amputation. Trauma injuries are commonly contaminated, and therefore patients are at a high risk of infection. As a single-arm study, the comparators for the HAV results were benchmark outcomes for treatment with synthetics grafts based on a systematic literature search. The principal means of evaluation was comparability of secondary patency (blood flow) at 30 days, with primary patency (blood flow without intervention) also evaluated. Secondary comparisons comprised of improvement in rates of amputation and rates of infection at 30 days. 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 was a success, and the principal comparison of 30-day secondary patency for the HAV in the clinical trial was 90.2% for the extremity patients (89.9% for total patients) compared to 81.1% historically reported for synthetic grafts. Primary patency for total HAV patients and for extremity patients was 81.2% and 84.3%, respectively, although no comparison to synthetic graft primary patency was possible since this measure was not reported in the benchmark publications. For the secondary comparison of amputation rates, the HAV demonstrated an improvement with a rate of 9.8% for extremity patients (10.1% for total patients) compared to 20.6% historically reported for synthetic grafts. For the secondary comparison of infection rate, the HAV demonstrated an improvement, with a rate of 2.0% for the extremity patients (2.9% for the total patients) compared to 8.9% historically reported for synthetic grafts. There were no unexpected safety signals for the HAV in this study. An expanded presentation of the results of the V005 trial is expected to be made at the Veith Symposium, a major vascular surgery meeting, in New York City on November 16, 2023.

"We are elated that the V005 results support our expectation that the HAV may improve the treatment and outcome of patients suffering major traumatic Injuries,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “We are pleased to reach this major milestone, and thank the medical professionals, patients, advisors and our own team members who contributed to the success of this clinical trial. We now look forward to moving to completion of our BLA filing and planned commercial launch.”

Humacyte is currently preparing a BLA for use of the HAV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and saphenous vein is not feasible to the FDA before the end of the year. In May 2023, Humacyte’s 6 mm HAV received the Regenerative Medicine Advanced Therapy (RMAT) Designation from the FDA for urgent arterial repair following extremity vascular trauma, which provides a basis for priority review of the BLA by the FDA. Based on guidance from the FDA, Humacyte plans to pursue a traditional BLA approval which may eliminate the requirement for a post-approval confirmatory study.

The FDA has advised Humacyte to include patient outcomes from a humanitarian program conducted in Ukraine in its BLA submission. As a result, the Company is also reporting preliminary results for the 16 extremity patients from Ukraine who provided consent for use of their results. For this population, 30-day secondary patency for the HAV was 93.8% compared to 81.1% historically reported for synthetic grafts. The rate of amputation for the HAV was 0.0% compared to 20.6% historically reported for synthetic grafts. The rate of infection for the HAV was 0.0% compared to 8.9% historically reported for synthetic grafts.
   
The HAV, a bioengineered tissue, is under investigation as an infection-resistant alternative for revascularization. Designed to be ready off-the-shelf, the HAV has the potential to save valuable time for surgeons and to reduce discomfort and complications for patients. The HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, providing 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.