Benzinga | Apr 21, 2021 08:05AM EDT

Alpha Healthcare Acquisition M&A Partner Humacyte Announces Long-Term Follow-Up Data From Phase 2 Vascular Access Trial

* Five-year outcomes demonstrate HAV retained durability and structural integrity, potentially offering a safe and viable option for long-term hemodialysis

* Long-term explant samples demonstrate progressive host cell remodeling to create living vascular tissue; no indication of rejection of HAV

* Results support continued evaluation of HAV for vascular access, vascular trauma and peripheral arterial disease

DURHAM, N.C., April 21, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that five-year data from a Phase 2 clinical trial of patients receiving the human acellular vessels (HAV) for arteriovenous (AV) access in hemodialysis suggest the long-term durability and functional hemodialysis access of the HAV.

Secondary patency was 58.2% (95% CI; 39.2-73.1%) at five years, after censoring for deaths and withdrawals, suggesting that the HAV may provide a promising long-term hemodialysis option. The data also showed a substantial reduction in infection rates compared to published rates for ePTFE. Long-term explant samples showed progressive host cell remodeling with the formation of a neo-adventitia, the vessel wall containing vascular smooth muscle cells and lumen of HAV was lined with endothelial cells. In the five years after HAV implantation, no infections of the HAV were noted and no clinical evidence of immunological rejection were observed in this Phase 2 trial.

"These long-term data reinforce the initial results and help demonstrate that the HAV has the potential to provide durable, functional hemodialysis access, and repopulate with the patient's own cells while maintaining a robust safety profile," said Jeffrey Lawson, M.D., Ph.D., Chief Surgical Officer of Humacyte. "We are encouraged by these results, which buttress our robust body of evidence supporting the potential of the HAV to be a pioneering engineered, off-the shelf, regenerative human tissue, and look forward to the continued evaluation of HAV in our ongoing Phase 3 trials in vascular access, as well as our Phase 2/3 trial in vascular trauma and Phase 2 trials in peripheral arterial disease."

The prospective Phase 2 trials evaluated HAV in adult patients with end-stage renal disease undergoing hemodialysis at six sites in the U.S. and Poland. The long-term follow-up data is based upon the cohort of patients in Poland who continued routine dialysis with HAV and were followed for conduit status every three months following completion of the main portion of the study (month 24) through at least five years, the longest-term follow-up to any trial of any implanted engineered human connective tissue.

The data were presented in an oral presentation at the Charing Cross (CX) International Symposium by Dr. Lawson and have been submitted for publication in a peer-reviewed journal.

On February 17, 2021, Alpha Healthcare Acquisition Corp. (NASDAQ:AHAC) ("AHAC"), a special purpose acquisition company, and Humacyte announced the execution of a definitive business combination agreement along with a fully committed $175 million PIPE financing agreement.