Kuria Therapeutics Awarded NIH Grant to Advance SCO-116 for Fuchs’ Endothelial Corneal Dystrophy
Phase I award will support studies of SCO-116 in human corneal tissue to further establish its potential as a non-surgical treatment for Fuchs’ dystrophy
Kuria Therapeutics, a biotechnology company developing novel small-molecule therapies for ophthalmic diseases, today announced that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Eye Institute/National Institutes of Health to support further preclinical development of SCO-116, the company’s lead topical NRF2 activator, for the treatment of Fuchs’ endothelial corneal dystrophy.
The funded studies will evaluate SCO-116 in cultured human donor corneas with guttae, a characteristic feature of Fuchs’ dystrophy. The research is designed to determine whether SCO-116 activates the NRF2 pathway in human corneal endothelial tissue and whether treatment can reduce apoptosis, or programmed cell death, of corneal endothelial cells.
Fuchs’ dystrophy is a progressive disease characterized by dysfunction and loss of corneal endothelial cells. These cells do not regenerate in humans and are responsible for pumping fluid from the cornea to maintain its transparency. Oxidative stress and mitochondrial dysfunction are important contributors to the disease, ultimately resulting in corneal swelling, impaired vision and, in advanced cases, the need for corneal transplantation.
SCO-116 is a potent small-molecule activator of NRF2, a transcription factor that regulates cellular antioxidant defenses, mitochondrial function and other protective responses to oxidative stress. Kuria is developing a preservative-free topical ophthalmic formulation of SCO-116, KTX-1161, with the goal of treating Fuchs’ patients earlier in the course of disease and preserving corneal endothelial-cell function.
“This award provides an opportunity to extend our work with SCO-116 into human corneal tissue that closely reflects the biology of Fuchs’ dystrophy,” said Misty Stevens, PhD, Chief Operating Officer of Kuria Therapeutics and Principal Investigator on the new grant. “Demonstrating NRF2 activation and protection of corneal endothelial cells in these models would provide important additional evidence supporting the potential of SCO-116 as a disease-modifying treatment for Fuchs’ and complement our ongoing IND-enabling development program.”
The Phase I program includes two principal objectives: demonstrating SCO-116-mediated NRF2 activation in human corneas with guttae and evaluating the ability of SCO-116 to reduce corneal endothelial cell apoptosis. Successful completion of either predefined milestone would support further evaluation of SCO-116 in larger studies of Fuchs’ dystrophy.
Kuria has previously completed a pre-IND meeting with the U.S. Food and Drug Administration and received agreement on its nonclinical and early clinical development plans for KTX-1161. The company is advancing SCO-116 through IND-enabling development toward initial clinical evaluation 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.