Humacyte plans Biologics License Application (BLA) following completion of enrollment of 350 patients globally and collection of 12-month post-implantation patient data
RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Humacyte, an innovator in biotechnology and regenerative medicine, announced today that it has completed enrollment of 350 evaluable subjects for its Phase III HUMANITY® study of HUMACYL®, Humacyte’s investigational human acellular vessel (HAV). Conducted across 40 sites in the U.S., Europe and Israel, this pivotal Phase III clinical trial evaluates the efficacy and safety of the bioengineered blood vessel as a conduit for hemodialysis in patients with End-Stage Renal Disease (ESRD) requiring renal replacement therapy and who are not candidates for fistula.
Humacyte expects 12-month post-implantation patient data from the study to be available in late-2018. After analyzing this data, the company plans to file a BLA to seek marketing authorization for HUMACYL. To expedite the review process, Humacyte was granted the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration’s (FDA) earlier this year.
“We’ve achieved a very important milestone for our company by completing enrollment of this pivotal trial. The HUMANITY trial evaluates the potential of our bioengineered human acellular vessels to create a longer-lasting, more durable vascular access compared to expanded polytetrafluoroethylene (ePTFE) for dialysis in patients with ESRD. With the support of our clinical partners, patients, and employees, we’ve accomplished this critical goal in one of the largest prospective clinical studies conducted in the study of hemodialysis access,” said Carrie S. Cox, Chairman and Chief Executive Officer of Humacyte. “After we collect the next 12 months of data in patients implanted with HUMACYL, we plan to submit the application to gain the necessary regulatory approvals to commercialize HUMACYL, and bring our innovation to patients who need an alternative approach to vascular access.”
A key objective and a clinical endpoint of the Phase III study is to compare the secondary patency of the HAV to that of ePTFE grafts, as a conduit for hemodialysis. The study population includes patients suffering with ESRD requiring hemodialysis, who are not candidates for fistula but are suitable targets for implantation with an arteriovenous (AV) prosthesis for dialysis access. Based on the Phase II clinical study outcomes published in The Lancet, Humacyte anticipates that HUMACYL will offer a safe and effective alternative for vascular access that can become “the patient’s own” over time. Results of this prospective, open-label, randomized, two-arm, comparative study are planned to support an application for marketing authorization of the vascular access conduit in the US, Europe, and Israel. The company also expects to obtain data from this study to determine whether the patency of HUMACYL, together with other potential positive, long-term, clinical outcomes with use of the HAV, may result in reduced health care costs in the care of hemodialysis patients.
Humacyte announced the commencement of the Phase III study of HUMACYL in May 2016. In addition to this Phase III trial, Humacyte is developing and plans to seek regulatory approval for additional clinical applications for its HAV, and the company recently announced the commencement of a U.S. Phase II clinical trial of the bioengineered vessel as a bypass graft in patients with peripheral arterial disease (PAD). The company is also planning to develop future pipeline products that may improve treatment outcomes for patients suffering from both vascular and non-vascular diseases.