Kiora Pharmaceuticals Granted U.S. Patent Expanding Protection for KIO-104 in the Treatment of Ocular Disease
Kiora Pharmaceuticals (NASDAQ: KPRX) has been granted US Patent No. 12,364,680 for KIO-104, expanding its protection for treating various ocular diseases. The patent covers treatment applications including ocular inflammation, uveitis, age-related macular degeneration, and refractive surgery complications, extending market exclusivity until 2043.
The company is currently conducting a Phase 2 clinical trial (KLARITY study) investigating KIO-104 in up to 28 patients at two dose levels for inflammatory retinal diseases, including posterior non-infectious uveitis and diabetic macular edema. KIO-104 functions by inhibiting the DHODH enzyme, reducing T-cell replication and inflammation.
Kiora Pharmaceuticals (NASDAQ: KPRX) ha ottenuto il brevetto statunitense n. 12.364.680 per KIO-104, ampliando la protezione per il trattamento di diverse malattie oculari. Il brevetto copre applicazioni terapeutiche tra cui infiammazione oculare, uveite, degenerazione maculare legata all'età e complicazioni della chirurgia refrattiva, estendendo l'esclusiva di mercato fino al 2043.
L'azienda sta attualmente conducendo uno studio clinico di Fase 2 (studio KLARITY) che valuta KIO-104 in fino a 28 pazienti a due livelli di dosaggio per malattie infiammatorie della retina, tra cui uveite posteriore non infettiva e edema maculare diabetico. KIO-104 agisce inibendo l'enzima DHODH, riducendo la replicazione delle cellule T e l'infiammazione.
Kiora Pharmaceuticals (NASDAQ: KPRX) ha recibido la patente estadounidense No. 12,364,680 para KIO-104, ampliando su protección para el tratamiento de diversas enfermedades oculares. La patente cubre aplicaciones de tratamiento que incluyen inflamación ocular, uveítis, degeneración macular relacionada con la edad y complicaciones de cirugía refractiva, extendiendo la exclusividad en el mercado hasta 2043.
La compañía está llevando a cabo actualmente un ensayo clínico de Fase 2 (estudio KLARITY) que investiga KIO-104 en hasta 28 pacientes con dos niveles de dosis para enfermedades inflamatorias de la retina, incluyendo uveítis posterior no infecciosa y edema macular diabético. KIO-104 funciona inhibiendo la enzima DHODH, reduciendo la replicación de células T y la inflamación.
Kiora Pharmaceuticals (NASDAQ: KPRX)가 KIO-104에 대해 미국 특허 번호 12,364,680을 획득하여 다양한 안구 질환 치료에 대한 보호 범위를 확장했습니다. 이 특허는 안구 염증, 포도막염, 연령 관련 황반변성, 굴절 수술 합병증을 포함한 치료 적용을 포함하며, 시장 독점권을 2043년까지 연장합니다.
회사는 현재 두 가지 용량 수준에서 최대 28명의 환자를 대상으로 염증성 망막 질환(후부 비감염성 포도막염 및 당뇨병성 황반부종 포함)을 조사하는 2상 임상시험(KLARITY 연구)을 진행 중입니다. KIO-104는 DHODH 효소를 억제하여 T세포 복제와 염증을 감소시키는 작용을 합니다.
Kiora Pharmaceuticals (NASDAQ : KPRX) s'est vu attribuer le brevet américain n° 12 364 680 pour KIO-104, élargissant sa protection pour le traitement de diverses maladies oculaires. Le brevet couvre des applications thérapeutiques incluant l'inflammation oculaire, l'uvéite, la dégénérescence maculaire liée à l'âge et les complications de la chirurgie réfractive, prolongeant l'exclusivité commerciale jusqu'en 2043.
L'entreprise mène actuellement un essai clinique de phase 2 (étude KLARITY) évaluant KIO-104 chez jusqu'à 28 patients à deux niveaux de dose pour des maladies inflammatoires de la rétine, notamment l'uvéite postérieure non infectieuse et l'œdème maculaire diabétique. KIO-104 agit en inhibant l'enzyme DHODH, réduisant la réplication des lymphocytes T et l'inflammation.
Kiora Pharmaceuticals (NASDAQ: KPRX) wurde das US-Patent Nr. 12.364.680 für KIO-104 erteilt, wodurch der Schutz für die Behandlung verschiedener Augenerkrankungen erweitert wird. Das Patent umfasst Behandlungsanwendungen wie Augenentzündungen, Uveitis, altersbedingte Makuladegeneration und Komplikationen bei refraktiver Chirurgie und verlängert die Marktexklusivität bis 2043.
Das Unternehmen führt derzeit eine Phase-2-Studie (KLARITY-Studie) durch, in der KIO-104 bei bis zu 28 Patienten in zwei Dosierungsstufen für entzündliche Netzhauterkrankungen, einschließlich posteriore nicht-infektiöse Uveitis und diabetisches Makulaödem, untersucht wird. KIO-104 wirkt durch Hemmung des DHODH-Enzyms, wodurch die T-Zell-Replikation und Entzündungen reduziert werden.
- None.
- Early-stage drug development with no guaranteed approval
- Small patient sample size (28) in Phase 2 trial
Insights
Kiora's new patent strengthens KIO-104's market exclusivity until 2043, significantly enhancing the company's ocular disease treatment portfolio.
Kiora Pharmaceuticals has secured a critical intellectual property victory with their newly granted US Patent No. 12,364,680 for KIO-104. This patent provides broad therapeutic coverage across multiple ocular conditions including inflammation, uveitis, age-related macular degeneration, and complications from refractive surgery. The patent's scope extends to various dosing schedules and formulation elements, creating multiple layers of protection.
The patent's extension of market exclusivity through 2043 represents approximately 18 years of protection, substantially longer than the typical patent life remaining after clinical development. This timing suggests Kiora has successfully employed strategic patent filing tactics to maximize KIO-104's commercial potential.
KIO-104's mechanism of action - inhibiting the mitochondrial enzyme DHODH to reduce T-cell replication and function - offers a differentiated approach compared to current standard treatments. The compound potentially addresses the limitations of steroids and systemic anti-inflammatories, which often come with significant side effect profiles.
The ongoing Phase 2 KLARITY trial investigating two dose levels across multiple inflammatory retinal conditions will be pivotal in determining which specific indication(s) offer the strongest efficacy signal. This adaptive trial design allowing for dose expansion based on initial results demonstrates efficient clinical development strategy, potentially accelerating time-to-market for the most promising applications.
For a clinical-stage biotech company, this patent strengthens Kiora's negotiating position for potential partnerships or licensing deals while providing a substantial runway for commercialization efforts should KIO-104 receive regulatory approval.
Encinitas, California--(Newsfile Corp. - July 22, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) today announced it has received a patent (US Patent No. 12,364,680) covering KIO-104 for the treatment of a wide range of ocular diseases. This includes, but is not limited to, the following conditions: ocular inflammation, uveitis, age-related macular degeneration, and complications from refractive surgery. Additionally, the patent covers varying dosing schedules, necessary excipients, among other novel methods for optimizing treatment of ocular inflammatory diseases. This patent issuance is expected to further strengthen the protection of KIO-104 and extend market exclusivity into 2043.
"Securing this patent builds on our IP strategy to protect KIO-104 around its proprietary structure, delivery methods, formulation, and therapeutic applications," said Brian M. Strem, PhD, President & Chief Executive Officer of Kiora Pharmaceuticals. "This specific patent is significant in its breadth of therapeutic applications."
KIO-104 is a potent small molecule in development for inflammatory retinal diseases. It offers an alternative to steroids or systemic anti-inflammatory drugs, both of which have established limitations including undesirable side effects.
A multicenter Phase 2 clinical trial, the KLARITY study, is currently screening patients to investigate KIO-104 in up to 28 patients at two dose levels across several forms of inflammatory retinal disease. These diseases include posterior non-infectious uveitis and diabetic macular edema, conditions where inflammation is associated with vision-threatening changes. Results from the initial stage of the study will inform dose expansion into one or more specific indications.
KIO-104 works by inhibiting the mitochondrial enzyme DHODH, which plays a crucial role in the synthesis of key building blocks of DNA and RNA. Without these, T-cell replication is significantly reduced. These building blocks also serve as key cofactors required for T-cell function. Having fewer building blocks thus also dampens the ability of T-cells to drive inflammation.
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 and short-term investments on hand to fund operations for specific periods, and the ability to timely complete planned initiatives for 2025, including Phase 2 clinical development of KIO-301 and KIO-104. 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 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, 2025 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.
Contact:
Investors@kiorapharma.com
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FAQ
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