Kuria Therapeutics, Inc.

- Clear path forward to initiate two planned Phase 2 clinical trials with KTX-1161 LITTLE ROCK, Ark.--(BUSINESS WIRE)-- Kuria Therapeutics, a pharmaceutical company developing novel ophthalmic and dermal therapeutics, is pleased to announce it has completed a pre-Investigational New Drug ("IND") interaction with the U.S. 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. About Kuria Therapeutics, Inc.: Kuria Therapeutics, Inc. is a US-based pharmaceutical company dedicated to the development of novel therapeutics for ophthalmic and dermal disease. We are a team of seasoned life science executives and entrepreneurs with decades of experience in building biotechnology companies, running complex multi-national development programs, managing alliances with partners, and building relationships with clinicians, investors, vendors, and patient groups. For more information, visit .

KANAGAWA, Japan & LITTLE ROCK, Ark.--(BUSINESS WIRE)-- SCOHIA PHARMA, Inc, a Japanese biotech company dedicated to developing medicines for lifestyle-related diseases with high unmet needs, and Kuria Therapeutics, Inc., a U.S. pharmaceutical company developing novel therapeutics for ophthalmic and dermal diseases, today announced that the U.S. Patent Office has issued a composition-of-matter patent covering SCO-116, a novel Nrf2 activator being developed by Kuria for prevention and treatment of eye and skin diseases. U.S. Patent 11,518,763 covers a novel series of macrocyclic molecules discovered by SCOHIA PHARMA, including SCO-116, which activate Nrf2 and are useful for a broad array of diseases involving oxidative stress and inflammation. The Nrf2 pathway is widely recognized as the master regulator of the antioxidant response, and plays a key role in cellular defense against external insults and pathogens, as well as the regulation of the inflammatory response. This U.S. Patent is solely owned by SCOHIA PHARMA, and Kuria Therapeutics holds an exclusive, worldwide license to develop SCO-116 for topical treatment of eye and skin diseases. SCOHIA PHARMA retains the worldwide rights to SCO-116 other than the rights which are exclusively licensed to Kuria Therapeutics. “We are pleased that the U.S. Patent Office has issued this critical patent covering the novel chemical matter discovered in our laboratories,” commented Masanori Watanabe, President, CEO, and CSO of SCOHIA PHARMA. “At SCOHIA we are dedicated to discovering new molecules that can become medications for important unmet medical needs, and this latest patent affirms our team’s creativity and passion for innovation.” “The issuance of the U.S. Patent covering SCO-116 is a key development for us, as well,” stated Dr. Keith Ward, President and Chief Executive Officer of Kuria Therapeutics. “When we licensed topical development rights for skin and eye disease last year, we were confident in this outcome, and achieving composition-of-matter coverage for our key development molecule is an important milestone for Kuria.” About SCO-116: SCO-116 is a novel Nrf2 activator originated by SCOHIA which selectively inhibits the interaction of Nrf2 and KEAP1* through non-covalent binding. Unlike many other putative Nrf2 activators under development which covalently bind to KEAP1, SCO-116 is expected to exhibit a favorable safety pro of its selectivity. Initial one-week toxicity studies in rats and monkeys with SCO-116 have demonstrated a favorable safety and tolerability profile. SCO-116 has the potential to prevent and/or treat diverse diseases with high unmet medical needs such as chronic kidney diseases, diabetic kidney diseases, lung diseases, and liver diseases such as nonalcoholic steatohepatitis, as well as eye and skin diseases. *KEAP1 acts as a regulator of Nrf2 by targeting it for ubiquitination and subsequent proteasome-dependent degradation. About Kuria Therapeutics, Inc.: Kuria Therapeutics, Inc. is a US-based pharmaceutical company dedicated to the development of novel therapeutics for ophthalmic and dermal disease. We are seasoned life science executives and entrepreneurs with decades of experience in building biotechnology companies, running complex multi-national development programs, managing alliances with partners, and building relationships with clinicians, investors, vendors, and patient groups. For detailed information about Kuria Therapeutics, Inc., please visit . About SCOHIA PHARMA, Inc.: SCOHIA PHARMA, Inc. is a drug discovery bioventure focusing on the field of lifestyle-related diseases such as cardiovascular, metabolic, and renal diseases where high unmet medical needs still remain. Our R&D team has a rich pipeline and track record in each stage of drug development, including compound discovery, drug evaluation, and clinical development, which makes us special. For detailed information about SCOHIA PHARMA, Inc., please visit .

June 27, 2022 13:00 UTC - Kuria is granted exclusive worldwide rights to develop, manufacture, and commercialize asset for ocular and dermatologic diseases with localized therapeutic application; SCOHIA PHARMA to receive upfront payment plus up to 67 million USD in potential regulatory, development, and commercial milestones KANAGAWA, Japan & LITTLE ROCK, Ark.--(BUSINESS WIRE)-- Kuria Therapeutics, Inc., a US pharmaceutical company developing novel therapeutics for ophthalmic and dermal diseases, and SCOHIA PHARMA, Inc, a Japanese biotech company dedicated to developing medicines for lifestyle-related diseases with high unmet needs, today announced that the companies have entered into a licensing agreement under which Kuria may develop, manufacture, and commercialize worldwide the locally delivered formulations of SCO-116, one of SCOHIA’s internally discovered novel Nrf2 activators, for prevention and/or treatment of eye and skin diseases. The initial topical ophthalmic solution product candidate containing SCO-116 has been designated by Kuria as KTX-101. Under the terms of the agreement, SCOHIA PHARMA will receive an upfront payment as well as additional milestone payments of up to USD 67 million if certain global regulatory, development, and sales milestones are achieved. SCOHIA PHARMA is also eligible to receive tiered royalties as a percentage of net sales. Kuria will be responsible for worldwide development, manufacturing, and commercialization in the selected indications with the oversight of a Joint Steering Committee comprised of individuals from both companies, while SCOHIA PHARMA retains the worldwide rights for SCO-116 for local delivery other than for eye and skin diseases as well as the systemic formulation. The Nrf2 pathway is widely recognized as the master regulator of the antioxidant response, and plays a key role in cellular defense against external insults and pathogens, as well as the regulation of the inflammatory response. Activation of Nrf2 may be beneficial in a wide array of diseases of the eye and skin involving oxidative stress and inflammation, and has been demonstrated to be beneficial in preclinical models of multiple eye diseases, including ocular surface disease, corneal dystrophies, glaucoma, macular degeneration, and diabetic eye disease. The R&D team at SCOHIA has discovered SCO-116, a novel, potent, selective activator of the Nrf2 pathway with demonstrated activity in multiple animal disease models. The licensing agreement announced today will allow Kuria to develop locally delivered formulations of SCO-116 in ophthalmic and dermal disease. “We are excited about the opportunity to initiate our development efforts with the Nrf2 activator discovered by SCOHIA PHARMA,” stated Dr. Keith Ward, President and Chief Executive Officer of Kuria Therapeutics. “The R&D team at SCOHIA executed a world-class discovery effort to identify and characterize a series of novel Nrf2 activators, and we are honored to partner with such a high-quality team to explore the therapeutic potential of SCO-116 in multiple ophthalmic and dermal diseases.” “With their deep knowledge and experience in ophthalmology and the development of Nrf2 activators, we are confident that Kuria will be an excellent partner to accelerate development of SCO-116 and deliver it to patients with skin and eye diseases awaiting novel therapies,” added Masanori Watanabe, President, CEO, and CSO of SCOHIA PHARMA. “Kuria’s development of locally delivered therapy directly to affected tissue will complement our efforts to develop SCO-116 systemically in diseases of the liver, kidney, and other organs and add significant value.” About SCO-116: SCO-116 is a novel Nrf2 activator originated by SCOHIA which selectively inhibits the interaction of Nrf2 and KEAP1* through non-covalent binding. Unlike many other putative Nrf2 activators under development which covalently bind to KEAP1, SCO-116 is expected to exhibit a favorable safety pro of its selectivity. Initial one-week toxicity studies in rats and monkeys with SCO-116 have demonstrated a favorable safety and tolerability profile. SCO-116 has the potential to prevent and/or treat diverse diseases with high unmet medical needs such as chronic kidney diseases, diabetic kidney diseases, and liver diseases such as nonalcoholic steatohepatitis, as well as eye and skin diseases. *KEAP1 acts as a regulator of Nrf2 by targeting it for ubiquitination and subsequent proteasome-dependent degradation. About Kuria Therapeutics, Inc.: Kuria Therapeutics, Inc. is a US-based pharmaceutical company dedicated to the development of novel therapeutics for ophthalmic and dermal disease. We are a team of seasoned life science executives and entrepreneurs with decades of experience in building biotechnology companies, running complex multi-national development programs, managing alliances with partners, and building relationships with clinicians, investors, vendors, and patient groups. For detailed information about Kuria Therapeutics, Inc., please visit . About SCOHIA PHARMA, Inc.: SCOHIA PHARMA, Inc. is a drug discovery bioventure focusing on the field of lifestyle-related diseases such as cardiovascular, metabolic, and renal diseases where high unmet medical needs still remain. Our R&D team has a rich pipeline and track record in each stage of drug development, including compound discovery, drug evaluation, and clinical development, which makes us special. For detailed information about SCOHIA PHARMA, Inc., please visit .