Humacyte’s HAV Evaluated in Vascular Trauma and CLTI Studies

September 12, 2023—Humacyte, Inc. announced the presentation of findings from two studies of the company’s human acellular vessel (HAV) bioengineered tissue, which is under investigation as an infection-resistant alternative for revascularization.

First, the company announced on September 11 that results from an investigator-sponsored clinical study evaluating the investigational HAV in patients with chronic limb-threatening ischemia (CLTI) concluded that the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage. The study was conducted at the Mayo Clinic in Rochester, Minnesota, and presented at the Midwestern Vascular Conference in Minneapolis.

On September 12, Humacyte announced that the single-arm V005 phase 2/3 clinical trial of HAV in vascular trauma repair showed that the HAV had higher rates of patency and lower rates of amputation and infection compared to historic synthetic graft benchmarks. An expanded presentation of the results of the V005 trial is expected to be made at the VEITHsymposium in November.

The company notes that findings of the HAV in CLTI patients at the Mayo Clinic included the outcomes of 29 patients, with a mean age of 71 years and no available vein to use as a bypass graft; 97% of these patients had previously experienced unsuccessful revascularization procedures on the extremity and 21 (72%) had tissue loss or gangrene. Surgery in 22 (76%) patients necessitated a tibial artery target, a surgical procedure involving the fusion of two HAVs with 42-cm lengths to achieve the required bypass length. Technical success was achieved in each of these cases, with no HAV-related major adverse events reported. At a median follow-up of 9 months, the secondary patency rate was 72%, with a limb salvage rate of 86%.

Patients in the single-arm V005 study, which was conducted in the United States and Israel, had arterial injuries from gunshots, workplace injuries, car accidents, or other traumatic events. Of the 69 patients enrolled, 51 had a vascular injury of the extremities. This group comprised the primary evaluation cohort for the study and did not have saphenous vein available to use as a bypass graft, the standard of care; therefore, if they had not received the HAV, they likely would have been treated with synthetic grafts, ligation of the bleeding artery, and/or amputation, the company noted.

For comparison to the HAV results, the V005 study used benchmark outcomes for synthetic grafts based on a literature search. Secondary patency at 30 days was the study's principal point of evaluation, with primary patency also studied. Additional comparisons included improvement in amputation and infection rates of amputation.

According to the company, the principal comparison of 30-day secondary patency for the HAV was 90.2% for the extremity patients (89.9% for total patients) compared to the 81.1% historically reported for synthetic grafts. Primary patency rates for total HAV patients and for extremity patients were 81.2% and 84.3%, respectively, although no comparison to synthetic graft primary patency was possible because this measure was not reported in the benchmark publications, Humacye said.

Results reported by Humacyte include an amputation rate of 9.8% for extremity patients (10.1% for total patients) compared to the 20.6% historically reported for synthetic grafts. The infection rate was 2% for the extremity patients (2.9% for the total patients) compared to 8.9% historically reported for synthetic grafts. No unexpected safety signals for the HAV were reported.

Humacyte says it plans to file a Biologics License Application (BLA) with the FDA in Q4 2023 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.

The company stated that in May 2023, its 60-mm HAV received the Regenerative Medicine Advanced Therapy designation from the FDA for urgent arterial repair after 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 postapproval confirmatory study.

Additionally, the company noted that the FDA has advised Humacyte to include patient outcomes from a humanitarian program conducted in Ukraine in its BLA submission. As a result, Humacyte 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, reported Humacyte.