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Kiora Pharmaceuticals Receives Investigational New Drug Application Approval to Expand Phase 1b Study of KIO-301 in Inherited Retinal Diseases; To Enroll Patients with Choroideremia and Additional Patients with Late-Stage Retinitis Pigmentosa
Encinitas, California--(Newsfile Corp. - October 3, 2023) - Kiora Pharmaceuticals (NASDAQ: KPRX) has received Investigational New Drug Application approval in
About this update from Kiora Pharmaceuticals, Inc.
[{"type":"text","content":"Encinitas, California--(Newsfile Corp. - October 3, 2023) - Kiora Pharmaceuticals (NASDAQ: KPRX) has received Investigational New Drug Application approval in Australia to enroll up to six additional patients in the ABACUS study of KIO-301. ABACUS was initially designed to evaluate patients with Retinitis Pigmentosa (RP). Based on encouraging findings previously shared, Kiora sought this approval to evaluate additional patients with late-stage RP as well as those with late-stage Choroideremia (CHM), a rare form of hereditary retinal degeneration. Plans remain for Kiora to report topline results on the first six RP patients in the ABACUS study on November 4th at the American Academy of Ophthalmology retina subspecialty day.\nKiora previously reported preliminary data in late-stage RP patients finding KIO-301 safe and tolerable with promising signs of efficacy. KIO-301 is a small molecule photoswitch, a first-in-class therapeutic with the potential to restore vision across several inherited retinal diseases (IRDs), regardless of underlying gene mutations.\n\"Data collected from additional patients will provide further insight to guide continued stages of clinical development,\" explained Eric Daniels, M.D., Chief Development Officer at Kiora. \"We are now in a position to expand this 'gene mutation-agnostic approach' to generate further proof-of-concept in patients with late-stage CHM. The common denominator in both RP and CHM is rod and cone degeneration, and that is precisely why KIO-301 has a good opportunity to make an impact.\"\nChoroideremia is a rare X-linked, recessive, inherited retinal disorder affecting approximately 1 in 50,000 individuals. It is caused by a loss-of-function mutation in the CHM gene. Initial symptoms include loss of night vision and often leads to severe vision impairment and blindness. Kiora is working with the Choroideremia Research Foundation (CRF), the world's largest not-for-profit organization dedicated finding a cure for CHM, to assist in a deeper understanding of the disease as well as access to CRFs patient database and thought leaders to assist in trial enrollment and future study designs.\n\"Adding CHM into ABACUS is consistent with our sharpened focus in addressing orphan retinal diseases,\" added Dr. Daniels. \"Running programs in multiple IRDs will allow for operational efficiencies while...