27 June 2022 - - US-based pharmaceutical company Kuria Therapeutics, Inc and Japanese biotech company Scohia Pharma, Inc 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 companies said.

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 67m 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 range 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 and 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 will allow Kuria to develop locally delivered formulations of SCO-116 in ophthalmic and dermal disease.

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 profile because 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.

Kuria Therapeutics is a US-based pharmaceutical company dedicated to the development of novel therapeutics for ophthalmic and dermal disease.

Scohia Pharma, Inc. is a drug discovery bioventure focusing on the field of lifestyle-related diseases such as cardiovascular, metabolic, and renal diseases.