Kuria Therapeutics announced completion of an FDA consultation for a pre-investigational new drug (IND) and received positive feedback regarding its KTX-1161 development program for the treatment of corneal endothelial disease (CED).
Tell me about KTX-1161.
KTX-1161 is a topical ophthalmic solution formulation of SCO-116—a novel nuclear erythroid 2-related factor 2 (Nrf2) activator that has high solubility and permeability currently developed under a license from SCOHIA PHARMA.
The formulation is being developed to treat patients with CEDs such as Fuchs’ endothelial corneal dystrophy and those undergoing cataract surgery.
What are pre-IND consultations?
The FDA’s Center for Drug Evaluation and Research’s (CDER’s) pre-IND consulting program supports early communications between sponsors and new drug review divisions in order to provide guidance on issues relating to data—including rationale for human drug testing, design of certain studies, and potential uses of any proposed treatment studies in animal models—that is necessary for an IND submission.
Why did Kuria have a pre-IND consult?
According to the company, Kuria sought the FDA’s guidance on the design for a KTX-1161 phase 2 clinical program (as well as future phase 3 efforts), concurrence for its remaining non-clinical studies of KTX-1161, and input on clinical trial endpoints for future registrational studies.
What else?
The FDA waived several of the non-clinical studies on the basis that KTX-1161 has an anticipated low-systemic exposure associated with administration.
What’s next?
Stay tuned! With the FDA’s guidance on next steps for KTX-1161, Kuria is looking forward to partnering with them on the company’s future development program.