Kuria Therapeutics Completes Phase I Milestones Under NIH/NEI SBIR Fast Track Award
Milestone completion supports continued advancement of SCO-116 through IND-enabling development
Kuria Therapeutics, a biotechnology company developing novel small-molecule therapies for ophthalmic diseases, today announced the successful completion of all Phase I scientific milestones under its National Institutes of Health/National Eye Institute (NIH/NEI) Small Business Innovation Research (SBIR) Fast Track Phase I/II award supporting development of SCO-116.
Kuria has submitted the completed Phase I milestones to NIH as part of the process to transition to the Phase II portion of the Fast Track award. The milestone completion reflects continued progress in the IND-enabling development program for SCO-116, including Good Laboratory Practice (GLP) toxicology studies.
SCO-116 is Kuria’s lead topical NRF2 activator and is being developed as a potential non-surgical treatment for diseases of the corneal endothelium, including Fuchs’ endothelial corneal dystrophy. The NIH/NEI Fast Track award provides up to $2.3 million to fund IND-enabling toxicology studies intended to support a future Investigational New Drug (IND) application for SCO-116.
“Completion of the Phase I milestones represents another important step in the continued advancement of SCO-116,” said Keith Ward, PhD, Chief Executive Officer of Kuria Therapeutics. “The program continues to progress through IND-enabling GLP studies, and submission of these results to NIH positions us to transition into Phase II of the Fast Track award and continue moving SCO-116 toward the clinic.”
Subject to NIH administrative review, the Phase II portion of the award will support continued IND-enabling development of SCO-116. Completion of these studies is expected to form the core of an IND submission to the U.S. Food and Drug Administration to support an initial clinical proof-of-concept study in patients with Fuchs’ dystrophy.
About Kuria Therapeutics
Kuria Therapeutics is a biotechnology company focused on developing innovative small-molecule therapies for ophthalmic diseases with significant unmet medical need. The company’s lead programs target diseases of the corneal endothelium, with the goal of providing non-surgical treatment options that preserve vision and improve patient outcomes.