Humacyte announces two presentations at VEITHsymposium on HAV

Humacyte announced the presentation of positive V005 Phase 2/3 clinical trial results of the investigational Human Acellular Vessel, HAV, in the treatment of vascular trauma, as well as results from the treatment of wartime injuries in Ukraine. Results showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application, BLA, for the HAV for an indication in vascular trauma patients with the U.S. Food and Drug Administration, FDA, during the current quarter. 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 for whom the standard of care, saphenous vein, was not feasible or available to use as a bypass graft. Primary patency for the HAV was 81.2% for the extremity patients, 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 extremity patients 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 extremity patients compared to 8.4% historically reported for synthetic grafts. In the V005 trial, the most common reasons reported by clinicians for using the HAV instead of the standard of care, saphenous vein, was the need to avoid the time required to harvest saphenous vein, the quality of the patient’s vein, and concomitant injuries to the vein, suggesting that the ready, off-the-shelf feature of the HAV has the potential to save valuable time for surgeons in the restoration of blood flow. The FDA has advised Humacyte to include in the BLA submission patient outcomes from a humanitarian program conducted in Ukraine. Results for the 16 extremity patients from Ukraine who provided consent for use of their results in the BLA filing were also presented at the meeting, a set of data known as the “V017 trial.” The rate of success for treatment of patients with the HAV in the V017 trial was high, with a 30-day secondary patency of 93.8%, zero amputations, and zero cases of infection of the HAV. The results of a meta-analysis combining the V005 and V017 trials concluded that the HAV demonstrated higher patency with a 30-day secondary patency rate of 91.5% for the extremity patients compared to 78.9% historically reported for synthetic grafts. There were no unexpected safety signals for the HAV in the V005 and V017 studies. Common adverse events reported were anemia, vascular graft thrombosis, blood loss anemia, pyrexia, thrombocytopenia, constipation, nausea peripheral edema, and tachycardia. There were four deaths among the extremity patients in the V005 trial, and zero deaths in the V017 trial. There were no deaths among extremity patients in the V005 trial attributed to the HAV.