Encinitas, California--(Newsfile Corp. - February 13, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) today announced that the U.S. Patent and Trademark Office has issued a composition-of-matter patent (US-12209073-B2) on a specific crystalline form, or polymorph, of KIO-104. KIO-104 is a novel, non-steroidal anti-inflammatory, small molecule inhibitor of dihydroorotate dehydrogenase (DHODH). A Phase 2 clinical trial of KIO-104 for the treatment of retinal inflammation is expected to begin in the first half of 2025. This new patent is expected to extend protection of KIO-104 into 2043.
This newly issued patent, titled, Polymorphs of a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, provides important and expanded intellectual property protection for KIO-104, specifically covering a critical and unique polymorph. This distinct crystalline form covered by the patent offers enhanced molecular stability and solubility, which are critical to optimize the manufacturing of the drug substance.
"Securing this patent issuance further extends and strengthens our existing IP position, which includes previously issued methods of use, drug delivery and formulation patents," said Brian M. Strem, PhD, President & Chief Executive Officer of Kiora Pharmaceuticals. "The protection of this specific polymorph is crucial as it allows us to optimize production, stability and delivery in a proprietary way, which translates into enhanced opportunities and therapeutic potential of KIO-104."
A multicenter Phase 2 clinical trial, the KLARITY study, will investigate KIO-104 in up to 28 patients with macular edema, a condition where inflammation causes a build-up of fluid behind part of the retina and can be associated with adverse vision changes. KIO-104, as a potent, locally delivered small molecule, could provide a needed alternative to steroids or systemic anti-inflammatory drugs.
About Kiora Pharmaceuticals
Kiora Pharmaceuticals is a clinical-stage biotechnology company developing advanced therapies for retinal disease. We target critical pathways underlying retinal diseases using innovative small molecules to slow, stop, or restore vision loss. KIO-301 is being developed for the treatment of retinitis pigmentosa, choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of retinal inflammation. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH).
In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that could be relevant to investors. We encourage investors to follow us on X and LinkedIn as well as to visit our website and/or subscribe to email alerts.
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, Kiora's ability to execute on development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104 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, the sufficiency of existing cash on hand to fund operations for specific periods, the projected cash runway, the ability to timely complete planned initiatives for 2024, including phase 2 clinical development of KIO-301 and KIO-104, the potential for KIO-301 to be the first treatment options for patients with inherited degenerative diseases like RP, Kiora's plans to further fund development of KIO-104, the potential for KIO-104 to reduce inflammation, the timing of topline results from clinical trials of KIO-104, the potential for KIO-104 to apply to other retinal inflammatory diseases, the anticipated readout dates for Kiora's clinical trials and their likelihood of success, and expected trends for research and development and general and administrative spending in 2024. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release the ability to conduct clinical trials on a timely 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 25, 2024 or described in Kiora's other public filings including on Form 10-Q filed with the SEC on November 8, 2024. 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.
