Kuria Therapeutics Completes FDA Pre-IND Consultation for Topical Nrf2 Activator for Corneal Endothelial Disease
Kuria Therapeutics, a pharmaceutical company developing novel ophthalmic and dermal therapeutics, is pleased to announce it has completed a pre-Investigational New Drug interaction with the United States Food and Drug Administration (FDA) and received positive feedback on its development program for KTX-1161 for corneal endothelial disease.
KTX-1161 is a topical ophthalmic solution formulation of SCO-116, a novel Nrf2 activator being developed under a license from SCOHIA PHARMA. Kuria is developing KTX-1161 to treat patients with diseases of the corneal endothelium, including patients with Fuchs’ endothelial corneal dystrophy and patients undergoing cataract surgery.
The purpose of the pre-IND consultation was to gain FDA concurrence on Kuria’s nonclinical IND-enabling plans, as well as to seek FDA guidance on the design of the Phase 2 clinical program for KTX-1161. FDA gave clear guidance on the remaining nonclinical studies for KTX-1161, including the waiver of several studies based on the anticipated low systemic exposure associated with KTX-1161 administration. The FDA also provided collaborative input on the design of the planned clinical trials, as well as on clinical trial endpoints for future registrational studies.
“We are delighted by the positive, constructive, and practical feedback provided by the FDA during this pre-IND interaction,” stated Dr. Keith Ward, President and Chief Executive Officer of Kuria. “FDA’s guidance allows us to execute a streamlined nonclinical program for KTX-1161, and, following clearance of the IND, move directly to Phase 2 clinical development. Importantly, we are grateful to FDA for extending their guidance beyond our Phase 2 program to the design of future Phase 3 efforts. We look forward to continued partnership with FDA on our future development program.”
Corneal endothelial dysfunction is an important unmet medical need which may be caused by a variety of insults and diseases, converging on a final common pathophysiology comprising corneal swelling, loss of visual acuity, and blindness. There are no approved medications to treat patients with diseases of the corneal endothelium, with corneal transplant often the only available sight-saving therapeutic option. Extensive evidence supports the role of Nrf2 activation in promoting corneal endothelial function, and KTX-1161 may be applicable to multiple associated vision-threatening conditions.
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