The FDA has accepted Kiora Pharmaceutical’s investigational new drug application (NDA) for the initiation of a phase 2 study assessing KIO-101 to treat ocular presentation of rheumatoid arthritis and other autoimmune diseases (OPRA+).
Tell me more about KIO-101.
KIO-101 is a third-generation small molecule dihydroorotate dehydrogenase (DHODH) inhibitor—part of a class of non-steroidal autoimmune disease drugs—that reduces T-cell proliferation and ongoing proinflammatory cytokine release.
According to Kiora, KIO-101 is a topical eye drop with the potential to affect the eye’s local immune response that is responsible for ophthalmic signs and symptoms found in autoimmune diseases, such as rheumatoid arthritis (RA).
How about this phase 2 trial?
The trial is a multicenter, randomized, controlled, double-masked study that will enroll up to 120 patients who have autoimmune disease (RA, psoriatic disease, systemic lupus erythematosus, or fibromyalgia) with associated ocular signs and symptoms.
KIO-101 will be evaluated in two concentrations: 0.15% and 0.30%.
Tell me more.
Efficacy endpoints will assess the number of ocular signs and symptoms, such as corneal staining and any Schirmer’s test score changes at 12 weeks, as well as safety and tolerability measures.
What else?
Kiora expects to start patient enrollment (in Australia) within the first half of 2023.