Kiora Pharmaceuticals' KIO-201 Heals Wounds in Phase 2 Trial of Patients with Persistent Corneal Epithelial Defects
In a second presentation, Kiora shared additional positive results for its KIO-100 platform in the treatment of autoimmune uveitis.
Encinitas, California--(Newsfile Corp. - April 26, 2023) - Kiora Pharmaceuticals (NASDAQ:KPRX) presented results of a Phase 2 clinical trial for KIO-201 treating patients with Persistent Corneal Epithelial Defects (PCEDs) at the Association for Research in Vision and Ophthalmology (ARVO) Meeting in New Orleans.
KIO-201 is a chemically modified and cross-linked form of hyaluronic acid designed to accelerate corneal wound healing. The results of the clinical trial demonstrate that KIO-201 is a promising treatment for PCEDs, which are challenging to treat and can lead to vision loss.
Outcomes from the trial demonstrated the following:
- 5 of 8 patients (62.5%) achieved the primary endpoint of healing over the 4-week period.
- The greatest reduction in defect size occurred during the first week of therapy.
- The drug was safe and well tolerated with a total of 6 non-serious adverse events reported in 2 of 8 patients (25.0%). All AEs were reported by investigators to be unrelated to the study drug.
"There is a significant unmet need for a safe and effective treatment for patients with PCEDs, and we believe that KIO-201 has the potential to meet that need," said Brian M Strem, Ph.D., President and CEO of Kiora. "These results are consistent with the five previous clinical trials evaluating KIO-201 in other corneal wounds."
The presentation, titled, "KIO-201, a Crosslinked, Chemically Modified Form of Hyaluronic Acid, Improves Wound Healing in Patients with Persistent Corneal Epithelial Defect," was made by Enrique O. Graue-Hernandez, Principal Investigator of the study.
Corneal epithelial defects are a rare and debilitating condition that can result from a variety of causes, including trauma, infection, and surgery. These defects can lead to pain, impaired vision, and even blindness in severe cases.
The trial was designed as a single-arm, open label study. Patients were evaluated at various timepoints up to 28 days after receiving KIO-201 six times daily. The endpoints included safety and tolerability︎, as well as the percentage of patients achieving corneal healing and the associated time to corneal healing as determined by corneal fluorescein staining.
In a second poster presentation, Kiora shared results of a phase 1b trial for the treatment of autoimmune uveitis and cystoid macular edema (CME). Kiora's KIO-100 consists of a novel DHODH-inhibitor to control inflammation in the eye. The results of this clinical trial demonstrate that an intravitreal KIO-100 formulation is safe and has the potential to be further developed as a new intraocular therapy for autoimmune uveitis and CME. No toxic or other adverse events were observed, and vision increased in a dose-dependent manner.
About Kiora Pharmaceuticals
Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing products for the treatment of ophthalmic diseases. KIO-301 is being developed for the treatment of retinitis pigmentosa. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-101 is being developed for the treatment of the Ocular Presentation of Rheumatoid Arthritis ("OPRA"). It is a next-generation, non-steroidal, immuno-modulatory and small molecule inhibitor of Dihydroorotate Dehydrogenase ("DHODH") with what Kiora believes is best-in-class picomolar potency and a validated immune modulating mechanism (blocks T cell proliferation and proinflammatory cytokine release) designed to overcome the off-target side effects and safety issues associated with commercially available DHODH inhibitors. In addition, Kiora is developing KIO-201, a chemically cross-linked form of the natural polymer hyaluronic acid, designed to accelerate corneal wound healing.
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Forward-Looking Statements
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, the development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-101, KIO-201 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a f basis, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 23, 2023 or described in Kiora's other public filings. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law.
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