Oruka Therapeutics Announces Preclinical Data for ORKA-002 at the 2025 American Academy of Dermatology Annual Meeting
Oruka Therapeutics (ORKA) has revealed promising preclinical data for ORKA-002, their novel extended half-life monoclonal antibody targeting IL-17A/F, at the 2025 AAD Annual Meeting. The drug demonstrated a remarkable half-life of over 30 days in non-human primates - more than triple that of bimekizumab.
Key findings show that ORKA-002 could potentially enable dosing intervals of once every four months to twice yearly in humans, based on projected pharmacokinetics. The drug exhibits equivalent potency and similar binding affinity to bimekizumab, binding IL-17A and IL-17F with comparable picomolar affinity.
The company plans to dose the first subject with ORKA-002 in Q3 2025. The drug is being developed for treating chronic skin diseases, including plaque psoriasis and psoriatic arthritis.
Oruka Therapeutics (ORKA) ha svelato dati preclinici promettenti per ORKA-002, il loro nuovo anticorpo monoclonale a vita prolungata che mira a IL-17A/F, durante il Congresso Annuale AAD 2025. Il farmaco ha mostrato una vita media di oltre 30 giorni in primati non umani, più di tre volte quella del bimekizumab.
I risultati chiave mostrano che ORKA-002 potrebbe potenzialmente consentire intervalli di somministrazione di una volta ogni quattro mesi a due volte all'anno negli esseri umani, sulla base della farmacocinetica prevista. Il farmaco presenta una potenza equivalente e una affinità di legame simile al bimekizumab, legando IL-17A e IL-17F con affinità picomolare comparabile.
L'azienda prevede di somministrare il primo soggetto con ORKA-002 nel Q3 2025. Il farmaco è in fase di sviluppo per il trattamento di malattie cutanee croniche, tra cui la psoriasi a placche e l'artrite psoriasica.
Oruka Therapeutics (ORKA) ha revelado datos preclínicos prometedores para ORKA-002, su novedoso anticuerpo monoclonal de vida media prolongada que se dirige a IL-17A/F, en la Reunión Anual AAD 2025. El medicamento demostró una vida media de más de 30 días en primates no humanos, más de tres veces la de bimekizumab.
Los hallazgos clave muestran que ORKA-002 podría permitir intervalos de dosificación de una vez cada cuatro meses a dos veces al año en humanos, basado en la farmacocinética proyectada. El medicamento presenta una potencia equivalente y una afinidad de unión similar a la de bimekizumab, uniendo IL-17A e IL-17F con afinidad picomolar comparable.
La compañía planea dosificar al primer sujeto con ORKA-002 en Q3 2025. El medicamento se está desarrollando para tratar enfermedades cutáneas crónicas, incluyendo psoriasis en placas y artritis psoriásica.
Oruka Therapeutics (ORKA)는 2025 AAD 연례 회의에서 IL-17A/F를 표적하는 새로운 반감기를 가진 단클론 항체 ORKA-002에 대한 유망한 전임상 데이터를 공개했습니다. 이 약물은 비인간 영장류에서 30일 이상의 반감기를 나타내어 bimekizumab의 세 배 이상입니다.
주요 발견에 따르면 ORKA-002는 예상되는 약물 동태학에 따라 인간에서 4개월에 한 번에서 연 2회의 투여 간격을 가능하게 할 수 있습니다. 이 약물은 bimekizumab과 동등한 효능과 유사한 결합 친화성을 보여주며, IL-17A 및 IL-17F에 대해 비교 가능한 피코몰 친화성으로 결합합니다.
회사는 2025년 3분기에 ORKA-002로 첫 번째 피험자를 투여할 계획입니다. 이 약물은 판상 건선 및 건선 관절염을 포함한 만성 피부 질환 치료를 위해 개발되고 있습니다.
Oruka Therapeutics (ORKA) a révélé des données précliniques prometteuses pour ORKA-002, leur nouvel anticorps monoclonal à demi-vie prolongée ciblant IL-17A/F, lors de la réunion annuelle AAD 2025. Le médicament a démontré une demi-vie de plus de 30 jours chez des primates non humains, plus de trois fois celle du bimekizumab.
Les résultats clés montrent qu'ORKA-002 pourrait potentiellement permettre des intervalles de dosage de une fois tous les quatre mois à deux fois par an chez l'homme, en fonction de la pharmacocinétique projetée. Le médicament présente une puissance équivalente et une affinité de liaison similaire à celle du bimekizumab, liant IL-17A et IL-17F avec une affinité picomolaire comparable.
L'entreprise prévoit de doser le premier sujet avec ORKA-002 au Q3 2025. Le médicament est en cours de développement pour traiter des maladies cutanées chroniques, y compris le psoriasis en plaques et l'arthrite psoriasique.
Oruka Therapeutics (ORKA) hat vielversprechende präklinische Daten für ORKA-002, ihren neuartigen monoklonalen Antikörper mit verlängerter Halbwertszeit, der auf IL-17A/F abzielt, auf dem AAD-Jahrestreffen 2025 vorgestellt. Das Medikament zeigte eine Halbwertszeit von über 30 Tagen bei nicht-menschlichen Primaten - mehr als das Dreifache von Bimekizumab.
Wichtige Ergebnisse zeigen, dass ORKA-002 potenziell Dosierungsintervalle von einmal alle vier Monate bis zweimal jährlich beim Menschen ermöglichen könnte, basierend auf den projizierten Pharmakokinetiken. Das Medikament weist eine vergleichbare Wirksamkeit und ähnliche Bindungsaffinität zu Bimekizumab auf und bindet IL-17A und IL-17F mit vergleichbarer pikomolarer Affinität.
Das Unternehmen plant, im Q3 2025 das erste Subjekt mit ORKA-002 zu dosieren. Das Medikament wird zur Behandlung von chronischen Hauterkrankungen entwickelt, einschließlich Plaque-Psoriasis und psoriatischer Arthritis.
- Extended half-life 3x longer than competitor bimekizumab
- Potential for reduced dosing frequency (2-3 times/year)
- Equivalent potency to established drug bimekizumab
- Clear development timeline with first dosing in Q3 2025
- Still in preclinical stage, no human data available
- Faces competition from established bimekizumab
Insights
Oruka Therapeutics' preclinical data for ORKA-002 represents a potentially significant advancement in IL-17A/F inhibition for chronic skin conditions. The reported 30+ day half-life in non-human primates - over three times longer than bimekizumab - could translate to a remarkable reduction in dosing frequency for patients to just 2-3 times annually, compared to the much more frequent administration required with current therapies.
The comparable binding affinity and nearly identical epitope to bimekizumab, coupled with equivalent potency across multiple assay types, suggests ORKA-002 may maintain the established efficacy profile while dramatically improving the treatment burden. The company's development pathway appears derisked by leveraging the validated IL-17A/F inhibition mechanism that has already demonstrated clinical and commercial success with bimekizumab.
However, investors should note ORKA-002 remains in preclinical development with first-in-human dosing not expected until Q3 2025. The projected human half-life of 50-75 days, while promising, requires validation in clinical trials. If successful, this extended dosing profile could create a meaningful competitive advantage in the psoriasis and psoriatic arthritis markets where treatment adherence significantly impacts outcomes.
This represents the company's second program demonstrating exceptional half-life extension, potentially validating their technological platform beyond a single candidate.
The preclinical profile of ORKA-002 demonstrates several compelling characteristics that align with the industry's push toward less frequent dosing regimens for chronic conditions. The three-fold longer half-life compared to bimekizumab in non-human primates is particularly noteworthy, as extended half-life directly correlates with potential dosing convenience.
From a mechanism perspective, the data showing comparable picomolar affinity to both IL-17A and IL-17F targets suggests ORKA-002 maintains the dual inhibition that has proven clinically effective with bimekizumab. The cryo-EM structural analysis confirming nearly identical epitope binding further validates the approach while the YTE modification appears to be successfully extending half-life without compromising target engagement.
The company's projection that other YTE-modified antibodies have demonstrated 2-4x longer half-lives in humans than in NHPs provides reasonable support for their dosing interval estimates. If these projections hold true in clinical studies, a twice-yearly dosing regimen would represent a substantial improvement over current standards.
While the data is promising, the timeline to first-in-human studies in Q3 2025 indicates a lengthy development path ahead. The reference to bimekizumab's "remarkable launch" contextualizes the commercial opportunity, but also signals that ORKA-002 will enter a market with established competition, requiring clear differentiation beyond dosing frequency to achieve significant uptake.
Half-life in non-human primates (NHP) of more than 30 days, over three times longer than bimekizumab and expected to support a dose interval of two to three times per year
Equivalent potency to bimekizumab with similar binding affinity and epitope demonstrated in several preclinical assays
First subject dosed with ORKA-002 expected in Q3 2025
MENLO PARK, Calif., March 07, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced new preclinical data on ORKA-002, a novel extended half-life monoclonal antibody targeting IL-17A/F, from its presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting.
- ORKA-002 has an NHP half-life of more than 30 days following subcutaneous and intravenous administration, over three times longer than bimekizumab. Projections of ORKA-002 pharmacokinetics (PK) in humans indicate that a human half-life of approximately 50 days could enable dosing once every four months, while a human half-life of approximately 75 days could enable twice-yearly dosing. The NHP half-life observed for ORKA-002 supports the potential to achieve these extended dosing intervals given that other YTE-modified antibodies have had an approximately two to four times longer half-life in humans than in NHPs.
- ORKA-002 binds to a similar epitope with similar affinity to bimekizumab and shows equivalent potency across a variety of in vitro assays. ORKA-002 binds IL-17A and IL-17F with a comparable picomolar affinity as bimekizumab. Based on cryo-EM structural analysis, ORKA-002 binds to a nearly identical epitope to bimekizumab on both IL-17A and IL-17F. When assessed across multiple different assays in cell lines and primary cells, ORKA-002 also had comparable functional potency for IL-17A and IL-17F antagonism. These findings further derisk the development path for ORKA-002.
“We are highly encouraged by the exceptional properties of ORKA-002, including a half-life in NHPs that is, for the second time in two programs, one of the longest seen to date for any antibody,” said Lawrence Klein, Oruka’s Chief Executive Officer. “Bimekizumab has had a remarkable launch, showing the excitement around IL-17A/F inhibition. We believe ORKA-002 could offer an even better product profile to people with psoriasis, psoriatic arthritis, and additional indications.”
About ORKA-002
ORKA-002 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A/F. Dual inhibition of both IL-17A and IL-17F has shown superior efficacy compared to IL-17A inhibition alone in psoriasis (PsO) and other indications, as shown by the performance of Bimzelx (bimekizumab) compared to Cosentyx (secukinumab) and Taltz (ixekizumab) in Phase 3 trials. These therapies all utilize monthly maintenance dosing in PsO and psoriatic arthritis (PsA), except Bimzelx in PsO patients weighing <120 kg, where Q8W maintenance dosing is recommended. In contrast, ORKA-002 has the potential to be dosed just two to three times a year in PsO and PsA, which we believe could allow ORKA-002 to become the leading therapy in the IL-17 class. Data from studies in non-human primates and other preclinical assays show that ORKA-002 binds to a similar epitope with similar affinity as bimekizumab and has a significantly extended half-life over three times longer than bimekizumab.
About Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.
Forward Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-002, including timelines to clinical and data release milestones, the potential half-life and potency of ORKA-002, its potential dosing interval and its potential product profile. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K and its registration statement on Form S-1. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.
Investor Contact:
Alan Lada
(650)-606-7911
alan.lada@orukatx.com
FAQ
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