Encinitas, Calif.–(Newsfile Corp. – January 3, 2023) – Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) (“Kiora” or the “Company”) announced today that enrollment has been completed in its clinical study evaluating KIO-201 in patients with persistent corneal epithelial defects (“PCED”), a rare ocular condition characterized by non-healing sores on the surface of the eye. Results from the study are expected to be reported at an upcoming medical conference in the first half of 2023.
“This study is an important step in tackling some of the most challenging and difficult to treat corneal ulcers,” said Eric Daniels, M.D., Chief Development Officer at Kiora Pharmaceuticals. “Current standard of care for these patients is suboptimal in terms of outcomes and remains a significant burden on patients. We believe that KIO-201, an eye drop that can be easily administered at home, addresses many of these challenges. As part of our development strategy to address unmet and rare ophthalmic diseases, we have applied for Orphan Drug Designation of KIO-201 to the PCED.In addition, based on initial observations, we have begun planning discussions with the FDA for a Phase 3 registration study of KIO-201 in PCED.”
PCEDs are characterized by an inability of the cornea to properly repair the protective epithelial surface of the eye. This can be due to a number of underlying factors, including physical trauma, surgical injury, infections or inflammatory eye diseases. When the corneas are unable to heal, patients’ eyes are susceptible to recurrent infections, debilitating pain, scarring and reduced vision. It is estimated that there are fewer than 200,000 patients diagnosed annually in the United States with PCED[1].
The trial was designed as a single-arm, open-label study with ten patients (up to 20 eyes). Patients were evaluated at various time points up to 28 days after receiving KIO-201 six times daily. Endpoints included safety and tolerability︎, as well as the percentage of patients who achieved corneal healing and the associated time to complete corneal healing as determined by corneal fluorescein staining.
KIO-201 is a chemically modified, cross-linked form of the natural polymer Hyaluronic Acid (HA). HAs are involved in natural corneal healing but are thought to be limited by shortened ocular resonance time. Formulated as a convenient topical eye drop, KIO-201 provides a thin coating to the surface of the eye and serves as a protectant to facilitate and accelerate corneal re-epithelialization. The chemical modifications enable improved viscoelastic properties and prolong the ocular surface resonance time compared to standard hyaluronic acids.
Kiora Pharmaceuticals is a clinical-stage biotechnology company that develops and commercializes 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 hereditary 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, nonsteroidal, immunomodulatory, small molecule inhibitor of Dihydroorotate Dehydrogenase (“DHODH”) with what Kiora believes is best-in-class picomolar potency and a validated immunomodulatory mechanism (blocking T-cell proliferation and proinflammatory cytokine release) designed to overcome the off-target side effects and safety concerns associated with commercially available DHODH inhibitors. In addition, Kiora is developing KIO-201, a modified form of the natural polymer hyaluronic acid, designed to accelerate corneal wound healing.
In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that may be relevant to investors. We encourage investors to follow us on Twitter and LinkedIn as well as to visit our website and/or subscribe to email alerts.
Some of the statements in this press release are “forward-looking” and are made in accordance with the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements regarding, among other things, results from this study that could support Kiora’s efforts to advancing KIO-201 to more advanced stages of clinical development, the expected timing of results from the study, KIO-201’s ability to address corneal wound treatment challenges, development and commercialization efforts and other regulatory or marketing approval efforts related 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 achieved 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 in this press release, including, among other things, the ability to conduct clinical trials in a timely manner, market conditions and other conditions and certain risk factors described under the heading “Risk Factors” contained in Kiora’s amendment no. .1 to Annual Report on Form 10-K/A filed with the SEC on July 7, 2022 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 publish any update or revision of such statements to reflect any change in its expectations with respect thereto or any change in the events, conditions or circumstances on which such statement is based, except as required by law.
Investor ContactFrancina Agosti, PhD(617) 546-0742fagosti@reportablenews.com
[1] Vaidyanathan U, Hopping GC, Liu HY, et al. Persistent corneal epithelial defects: A review article. With Hypothesis Discov Innov Ophthalmol. 2019;8(3):163-176.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/150107
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