Aurion Biotech Announces Completion of Enrollment in Phase 1 / 2 Clinical Trial
2024-04-30
细胞疗法临床研究
AURN001 is an Allogeneic Cell Therapy Candidate for the Treatment of Corneal Edema Secondary to Corneal Endothelial Dysfunction
SEATTLE & CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)-- Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today 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,” said Michael Goldstein, MD, MBA, President and Chief Medical Officer of Aurion Biotech. “We enrolled and dosed subjects in six 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, 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. Ninety-seven 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 three (3) lines of vision at six (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.
About Corneal Endothelial Dysfunction
Corneal edema secondary to endothelial dysfunction is a sight-threatening and debilitating condition affecting millions of people throughout the world. When corneal endothelial cells die or degrade, they do not regenerate. If left untreated, corneal endothelial cell loss can cause corneal edema (swelling) and loss of vision. Although corneal transplants are effective, there are disadvantages with these procedures – PKP/DMEK/DSAEK – including limited donor organ supply. Transplants require a supply of donor corneas in a 1:1 ratio (one healthy donor cornea to treat each diseased one), yet it’s estimated that there is only one donor cornea available for every 70 diseased eyes.1 In addition, post-operative recovery for corneal transplant patients requires that they lie flat on their backs for up to three days, in order for the transplant to adhere to the corneal stroma.
About Aurion Biotech
Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. It received the prestigious Prix Galien award for best start-up in biotech. Its first candidate is for the treatment of corneal edema secondary to corneal endothelial disease, and the first clinically validated cell therapy for corneal care, having received regulatory approval in Japan. The Company has initiated clinical trials in the U.S. and Canada. Privately held, Aurion Biotech is backed by Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more, visit .
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