Aurion Biotech has dosed the first Canadian subject in its phase 1 / 2 clinical trial (ABA-1, CLARA) of AURN001, a cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction.
“We are very pleased to have begun dosing subjects in this trial in Canada,” said Michael Goldstein, MD, MBA, president and CMO of Aurion Biotech. “Treating subjects in both the United States and Canada in our CLARA trial is an important milestone in our clinical development program. We believe that our cell therapy has the potential to revolutionize the treatment of corneal patients throughout the world.”
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 phase 1 / 2 clinical trial (ABA-1, CLARA) is a prospective, multi-center, 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. Approximately 100 subjects will be randomized in sites in the U.S. and in Canada.
This 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.