Aurion Biotech Completes Enrollment In Phase 1/2 Clinical Trial of Allogeneic Cell Therapy Candidate

Aurion Biotech announced that it has completed dosing of all subjects in its phase 1/2 clinical trial (CLARA) of AURN001, an allogeneic cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction.

“Aurion Biotech is delighted that both enrollment and dosing in our phase 1/2 trial are now complete, and that it happened more rapidly than we expected,” Michael Goldstein, MD, MBA, President and Chief Medical Officer of Aurion Biotech, said in a company news release. “We enrolled and dosed subjects in 6 months, which speaks to the deep interest among physicians and patients for our allogeneic cell therapy, as well as the potentially large, unmet need for our elegant, minimally invasive procedure to treat this sight-threatening disease.”

AURN001 is a combination cell therapy product (biologic/drug) comprised of neltependocel (allogeneic human corneal endothelial cells [CECs]) and Y-27632 (an inhibitor of Rho-associated, coiled-coil containing protein kinase [ROCK]). AURN001 is intended to be administered to the eye as a one-time, intracameral injection.

The CLARA phase 1/2 clinical trial is a prospective, multicenter, randomized, double masked, parallel-arm cell dose-ranging clinical trial in subjects with corneal edema secondary to corneal endothelial dysfunction. The study will evaluate three different doses of neltependocel used in combination with Y-27632. In the trial, 97 subjects have been randomized at US & Canadian sites. The CLARA trial is designed to assess the safety, tolerability, and efficacy of AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction. The primary endpoint is the percentage of subjects who gain 3 lines of vision at 6 months.

Drug product for the CLARA trial was supplied by Aurion’s CDMO partner, Charles River Laboratories, from their production site in Memphis, TN.