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Kiora Reports KIO-101 is Safe and Tolerable; Topline Data Supports Advancing KIO-101 to a Phase 2 Study in Patients with Dry Eye Disease
Salt Lake City, Utah--(Newsfile Corp. - December 14, 2021) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX), ("Kiora" or the "Company") announced topline data
About this update from Kiora Pharmaceuticals, Inc.
[{"type":"text","content":"Salt Lake City, Utah--(Newsfile Corp. - December 14, 2021) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX), (\"Kiora\" or the \"Company\") announced topline data from its vehicle-controlled, randomized safety study of KIO-101 eyedrops. The study evaluated 24 healthy subjects and 21 patients diagnosed with ocular surface inflammation, a key driver of dry eye disease. The results demonstrated favorable safety and tolerability of KIO-101 as well as statistically significant improvements in conjunctival hyperemia, a key inclusion criterion for the 21 patients enrolled with ocular surface inflammation and a recognized clinical sign in patients with ocular surface inflammation and associated dry eye. These results warrant advancing KIO-101 into Phase 2 studies of longer duration. KIO-101 is a small molecule DHODH inhibitor representing a novel approach to addressing ocular inflammation and dry eye disease. Previous generations of DHODH inhibitors are currently approved to treat patients with the systemic autoimmune diseases, multiple sclerosis and rheumatoid arthritis.\n\"As an exploratory study, our predetermined analysis plan was limited to only formal comparisons between groups for pharmacokinetics, safety and tolerability. A post-hoc analysis on predefined secondary efficacy outcomes showed a meaningful reduction in conjunctival hyperemia, consistent with inhibition of both T-cell proliferation and proinflammatory cytokine release that we would expect from an immune modulating DHODH inhibitor,\" said Eric J Daniels, MD, Chief Development Officer of Kiora. \"These early signs of a drug-related effect on clinical outcomes are encouraging and support KIO-101's continued development for patients with ocular surface inflammation associated with dry eye disease.\"\nThe topline results and observations include the following:\n\nKIO-101 had a favorable safety and tolerability profile with no systemic serious adverse events (SAE) or ocular SAEs in any subjects tested.\nPharmacokinetic analysis demonstrated no detectable levels of KIO-101 in the plasma in the majority of subjects, consistent with the design of Kiora's ophthalmic formulation.\nTreatment with KIO-101 resulted in a statistically significant and clinically meaningful reduction in conjunctival hyperemia, an FDA accepted pivotal study \"sign endpoint\" for dry eye disease.\n\nResult...