Kiora Pharmaceuticals Secures U.S. Composition-of-Matter Patent Expanding Protection of Its Anti-Inflammatory Compound KIO-104
Kiora Pharmaceuticals (NASDAQ: KPRX) has secured a new composition-of-matter patent (US-12209073-B2) for a specific crystalline form of KIO-104, their novel non-steroidal anti-inflammatory compound. The patent extends protection until 2043 and covers a unique polymorph that offers enhanced molecular stability and solubility, important for optimizing drug manufacturing.
The company is preparing to launch the KLARITY study, a Phase 2 clinical trial in the first half of 2025, which will evaluate KIO-104 in up to 28 patients with macular edema. The compound, as a locally delivered small molecule DHODH inhibitor, aims to provide an alternative to steroids or systemic anti-inflammatory drugs for treating retinal inflammation.
Kiora Pharmaceuticals (NASDAQ: KPRX) ha ottenuto un nuovo brevetto per composizione di materia (US-12209073-B2) per una forma cristallina specifica di KIO-104, il loro nuovo composto anti-infiammatorio non steroideo. Il brevetto estende la protezione fino al 2043 e copre un polimorfo unico che offre una stabilità molecolare e una solubilità migliorate, fondamentali per ottimizzare la produzione di farmaci.
L'azienda si sta preparando a lanciare lo studio KLARITY, uno studio clinico di Fase 2 nella prima metà del 2025, che valuterà KIO-104 in fino a 28 pazienti con edema maculare. Il composto, come inibitore DHODH a piccole molecole somministrato localmente, mira a fornire un'alternativa agli steroidi o ai farmaci anti-infiammatori sistemici per il trattamento dell'infiammazione retinica.
Kiora Pharmaceuticals (NASDAQ: KPRX) ha obtenido una nueva patente de composición de materia (US-12209073-B2) para una forma cristalina específica de KIO-104, su nuevo compuesto antiinflamatorio no esteroideo. La patente extiende la protección hasta 2043 y cubre un polimorfo único que ofrece una estabilidad molecular y una solubilidad mejoradas, importantes para optimizar la fabricación de medicamentos.
La empresa se está preparando para lanzar el estudio KLARITY, un ensayo clínico de Fase 2 en la primera mitad de 2025, que evaluará KIO-104 en hasta 28 pacientes con edema macular. El compuesto, como un inhibidor DHODH de molécula pequeña administrado localmente, tiene como objetivo proporcionar una alternativa a los esteroides o a los medicamentos antiinflamatorios sistémicos para tratar la inflamación retinal.
Kiora Pharmaceuticals (NASDAQ: KPRX)는 특정 결정 형태의 KIO-104, 그들의 새로운 비스테로이드성 항염증 화합물에 대한 새로운 물질 조성 특허(US-12209073-B2)를 확보했습니다. 이 특허는 2043년까지 보호를 연장하며, 약물 제조 최적화에 중요한 독특한 다형체를 포함합니다.
회사는 2025년 상반기에 KLARITY 연구를 시작할 준비를 하고 있으며, 이는 최대 28명의 황반 부종 환자를 대상으로 KIO-104를 평가하는 2상 임상 시험입니다. 이 화합물은 국소적으로 전달되는 소분자 DHODH 억제제로서 망막 염증 치료를 위한 스테로이드나 전신 항염증제에 대한 대안을 제공하는 것을 목표로 합니다.
Kiora Pharmaceuticals (NASDAQ: KPRX) a obtenu un nouveau brevet de composition de matière (US-12209073-B2) pour une forme cristalline spécifique de KIO-104, leur nouveau composé anti-inflammatoire non stéroïdien. Le brevet protège jusqu'en 2043 et couvre un polymorphe unique qui offre une stabilité moléculaire et une solubilité améliorées, essentielles pour optimiser la fabrication de médicaments.
L'entreprise se prépare à lancer l'étude KLARITY, un essai clinique de Phase 2 dans la première moitié de 2025, qui évaluera KIO-104 chez jusqu'à 28 patients souffrant d'œdème maculaire. Le composé, en tant qu'inhibiteur DHODH de petite molécule administré localement, vise à fournir une alternative aux stéroïdes ou aux médicaments anti-inflammatoires systémiques pour traiter l'inflammation rétinienne.
Kiora Pharmaceuticals (NASDAQ: KPRX) hat ein neues Patent für eine Zusammensetzung (US-12209073-B2) für eine spezifische kristalline Form von KIO-104, ihrem neuartigen nicht-steroidalen entzündungshemmenden Wirkstoff, gesichert. Das Patent erstreckt sich bis 2043 und umfasst eine einzigartige Polymorphe, die eine verbesserte molekulare Stabilität und Löslichkeit bietet, was für die Optimierung der Arzneimittelherstellung wichtig ist.
Das Unternehmen bereitet sich darauf vor, die KLARITY-Studie zu starten, eine klinische Phase-2-Studie in der ersten Hälfte von 2025, die KIO-104 bei bis zu 28 Patienten mit Makulaödem evaluieren wird. Der Wirkstoff, als lokal verabreichtes kleines Molekül-DHODH-Inhibitor, zielt darauf ab, eine Alternative zu Steroiden oder systemischen entzündungshemmenden Arzneimitteln zur Behandlung von Netzhautentzündungen zu bieten.
- Secured new patent protection until 2043 for KIO-104
- Enhanced molecular stability and solubility properties for manufacturing optimization
- Phase 2 clinical trial planned for first half of 2025
- None.
Insights
The newly secured composition-of-matter patent for KIO-104's crystalline form represents a significant strategic asset for Kiora Pharmaceuticals. Composition-of-matter patents are considered the strongest form of pharmaceutical patent protection, as they're typically harder to challenge or work around compared to method-of-use or formulation patents. This particular patent, extending to 2043, provides nearly 20 years of market exclusivity from today.
The patent's focus on a specific polymorph is particularly valuable. Polymorphic patents protect distinct crystalline forms of compounds that can significantly impact drug manufacturing, stability, and bioavailability. By securing protection for an optimized crystalline form with enhanced stability and solubility, Kiora has effectively created a manufacturing moat that competitors would need to navigate around, even after other patents expire.
The timing of this patent is strategically aligned with KIO-104's development timeline. With Phase 2 trials beginning in 2025 for retinal inflammation, the extended protection through 2043 would cover the important commercial phase well beyond potential FDA approval. This extensive runway provides Kiora with significant leverage for potential licensing deals or partnerships, as pharmaceutical companies typically seek assets with at least 10-15 years of remaining patent life.
The enhanced molecular stability and solubility characteristics protected by this patent could translate into manufacturing cost advantages and potentially improved drug delivery efficiency. These factors are important for maintaining competitive margins in the pharmaceutical market and could provide Kiora with significant pricing flexibility once the product reaches commercialization.
KIO-104's development as a locally-delivered DHODH inhibitor represents a potentially significant advancement in treating retinal inflammation. The current standard of care for macular edema primarily relies on steroids or systemic anti-inflammatory drugs, both of which carry significant side effect profiles. A targeted, non-steroidal approach could address an important unmet medical need in this space.
The mechanism of DHODH inhibition is particularly interesting for ophthalmology applications. By targeting this enzyme, KIO-104 can modulate inflammatory responses without the tissue-damaging effects associated with long-term steroid use. The local delivery approach could provide optimal therapeutic concentrations at the target site while minimizing systemic exposure, potentially offering a superior safety profile compared to current systemic treatments.
The upcoming KLARITY study with 28 patients will be important in demonstrating KIO-104's efficacy in macular edema. The condition affects millions globally, with diabetic macular edema alone impacting approximately 21 million people worldwide. A successful local anti-inflammatory treatment could capture significant market share in this growing patient population.
The optimization of molecular stability and solubility through the patented crystalline form could translate into improved bioavailability and consistent drug delivery, critical factors for maintaining therapeutic levels in ocular tissues. This could potentially lead to better treatment outcomes and patient compliance compared to current options.
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.
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Contact:
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FAQ
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