Oruka Therapeutics Announces First Participants Dosed in Phase 1 Trial of ORKA-002, its Novel Half-life Extended Anti-IL-17A/F Antibody
Oruka Therapeutics (NASDAQ: ORKA) has begun dosing healthy volunteers in its Phase 1 trial of ORKA-002, a novel half-life extended monoclonal antibody targeting IL-17A/F for treating chronic skin diseases. The trial will evaluate safety, tolerability, and pharmacokinetics across three subcutaneous dose cohorts with approximately 24 participants.
The company expects to share interim data around year-end 2025 and plans to initiate a Phase 2 study in moderate-to-severe psoriasis in 1H 2026. Preclinical data suggests ORKA-002 could enable dosing two to three times per year for psoriasis patients, marking a significant improvement over current standard of care. The planned Phase 2 study will assess multiple dose levels with a primary endpoint of PASI 100 at week 16.
Oruka Therapeutics (NASDAQ: ORKA) ha iniziato la somministrazione di dosi a volontari sani nel suo studio di Fase 1 su ORKA-002, un nuovo anticorpo monoclonale a emivita prolungata che agisce su IL-17A/F per il trattamento delle malattie cutanee croniche. Lo studio valuterà sicurezza, tollerabilità e farmacocinetica in tre coorti con dosi sottocutanee, coinvolgendo circa 24 partecipanti.
L'azienda prevede di condividere dati intermedi entro la fine del 2025 e intende avviare uno studio di Fase 2 sulla psoriasi da moderata a grave nella prima metà del 2026. I dati preclinici indicano che ORKA-002 potrebbe permettere somministrazioni due o tre volte all'anno per i pazienti con psoriasi, rappresentando un notevole miglioramento rispetto agli standard attuali. Lo studio di Fase 2 pianificato valuterà diversi livelli di dose con l'obiettivo primario di raggiungere PASI 100 alla settimana 16.
Oruka Therapeutics (NASDAQ: ORKA) ha comenzado a administrar dosis a voluntarios sanos en su ensayo de Fase 1 con ORKA-002, un nuevo anticuerpo monoclonal de vida media prolongada dirigido a IL-17A/F para tratar enfermedades crónicas de la piel. El ensayo evaluará la seguridad, tolerabilidad y farmacocinética en tres cohortes con dosis subcutáneas, con aproximadamente 24 participantes.
La empresa espera compartir datos provisionales hacia finales de 2025 y planea iniciar un estudio de Fase 2 en psoriasis moderada a grave en la primera mitad de 2026. Los datos preclínicos sugieren que ORKA-002 podría permitir dosis dos o tres veces al año para pacientes con psoriasis, representando una mejora significativa respecto al tratamiento estándar actual. El estudio de Fase 2 evaluará múltiples niveles de dosis con un objetivo principal de PASI 100 en la semana 16.
Oruka Therapeutics (NASDAQ: ORKA)는 만성 피부 질환 치료를 위한 IL-17A/F를 표적으로 하는 새로운 반감기 연장 단일클론항체 ORKA-002의 1상 임상시험에서 건강한 지원자들에게 약물을 투여하기 시작했습니다. 이번 임상시험은 약 24명의 참가자를 대상으로 세 가지 피하 투여 용량 그룹에서 안전성, 내약성 및 약동학을 평가할 예정입니다.
회사는 2025년 말경 중간 결과를 발표할 계획이며, 2026년 상반기에 중등도-중증 건선 환자를 대상으로 한 2상 시험을 시작할 예정입니다. 전임상 데이터에 따르면 ORKA-002는 건선 환자에게 연 2~3회 투여가 가능할 것으로 보여 현재 표준 치료법 대비 큰 개선을 의미합니다. 계획된 2상 시험에서는 여러 용량 수준을 평가하며 16주차 PASI 100 달성을 주요 평가 지표로 삼습니다.
Oruka Therapeutics (NASDAQ : ORKA) a commencé à administrer des doses à des volontaires sains dans son essai de Phase 1 portant sur ORKA-002, un nouvel anticorps monoclonal à demi-vie prolongée ciblant IL-17A/F pour le traitement des maladies chroniques de la peau. L'essai évaluera la sécurité, la tolérabilité et la pharmacocinétique à travers trois cohortes de doses sous-cutanées, avec environ 24 participants.
L'entreprise prévoit de partager des données intermédiaires vers la fin de l'année 2025 et envisage de lancer une étude de Phase 2 sur le psoriasis modéré à sévère au premier semestre 2026. Les données précliniques suggèrent que ORKA-002 pourrait permettre des administrations deux à trois fois par an pour les patients atteints de psoriasis, ce qui représente une amélioration significative par rapport aux traitements standards actuels. L'étude de Phase 2 prévue évaluera plusieurs niveaux de dose avec pour critère principal le PASI 100 à la semaine 16.
Oruka Therapeutics (NASDAQ: ORKA) hat mit der Dosierung gesunder Freiwilliger in seiner Phase-1-Studie zu ORKA-002 begonnen, einem neuartigen monoklonalen Antikörper mit verlängerter Halbwertszeit, der auf IL-17A/F zur Behandlung chronischer Hauterkrankungen abzielt. Die Studie wird Sicherheit, Verträglichkeit und Pharmakokinetik in drei subkutanen Dosiskohorten mit etwa 24 Teilnehmern untersuchen.
Das Unternehmen erwartet, gegen Ende 2025 Zwischenberichte zu veröffentlichen und plant, im ersten Halbjahr 2026 eine Phase-2-Studie bei mittelschwerer bis schwerer Psoriasis zu starten. Präklinische Daten deuten darauf hin, dass ORKA-002 eine Dosierung zwei- bis dreimal jährlich für Psoriasis-Patienten ermöglichen könnte, was eine deutliche Verbesserung gegenüber dem aktuellen Standard darstellt. Die geplante Phase-2-Studie wird mehrere Dosierungsstufen prüfen mit dem primären Endpunkt PASI 100 in Woche 16.
- Preclinical data shows potential for reduced dosing frequency (2-3 times/year) compared to standard of care
- Company now has two assets (ORKA-001 and ORKA-002) in human trials
- ORKA-002 targets both IL-17A and IL-17F, which has shown superior results compared to IL-17A inhibition alone
- Phase 1 results won't be available until end of 2025
- Early-stage development with significant clinical trials ahead before potential commercialization
Insights
Oruka's IL-17A/F antibody enters clinical testing, with dosing frequency advantages potentially challenging established psoriasis treatments.
Oruka Therapeutics has reached a significant clinical milestone with their novel IL-17A/F inhibitor ORKA-002 entering human testing. This represents the second pipeline candidate to enter clinical trials for the company. The Phase 1 trial will enroll approximately 24 healthy volunteers across three dose cohorts to evaluate safety, tolerability, and pharmacokinetic profile, with data expected around year-end 2025.
The most compelling aspect of ORKA-002 is its potentially transformative dosing frequency. Preclinical data suggests it could require administration just 2-3 times per year for psoriasis patients - a substantial improvement over current standard-of-care biologics that typically require dosing every 1-3 months. This extended half-life could significantly improve treatment adherence and patient quality of life.
The company is positioning ORKA-002 strategically within the competitive IL-17 inhibitor landscape. They're specifically highlighting how their candidate targets both IL-17A and IL-17F, similar to bimekizumab (which has shown superior efficacy to IL-17A-only inhibitors like secukinumab in clinical trials). Management appears to be differentiating their approach from established IL-17A inhibitors like Cosentyx.
Pending Phase 1 results, Oruka plans to initiate a Phase 2 study in 1H 2026 for moderate-to-severe psoriasis with the ambitious primary endpoint of PASI 100 (complete skin clearance) at week 16. The company is also developing companion candidate ORKA-001 (likely an IL-23 inhibitor) and investigating a sequential combination approach (ORKA-021), suggesting a comprehensive pipeline strategy targeting multiple cytokine pathways in inflammatory skin conditions.
Pharmacokinetic and safety data from healthy volunteers anticipated around YE 2025
On track to initiate a Phase 2 study in 1H 2026
ORKA-002 preclinical data demonstrate the potential for dosing two to three times per year in psoriasis, a significant improvement over standard of care
MENLO PARK, Calif., May 20, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced that it has initiated dosing of healthy volunteers in its first clinical trial of ORKA-002, the Company’s novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A and IL-17F (IL-17A/F).
“With both ORKA-001 and ORKA-002 now in human trials, we are moving quickly to demonstrate the clinical differentiation of both assets,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Bimekizumab is launching extremely well as IL-17A/F has emerged as superior to IL-17A inhibition in several important indications. Uniquely, we could have the best targeting approaches for both IL-23p19 and IL-17A/F, potentially allowing us to offer the ideal regimen to patients through our ORKA-001 and -002 monotherapies and our ORKA-021 sequential combination.”
The ORKA-002 Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of ORKA-002 in approximately 24 healthy volunteers across three subcutaneous dose cohorts. Oruka expects to share interim data from this study around year end 2025.
Pending data from the Phase 1 trial, Oruka plans to initiate a Phase 2 study of ORKA-002 in moderate-to-severe psoriasis in the first half of 2026. The planned study design will evaluate the safety and efficacy of multiple dose levels and regimens of ORKA-002, with a primary endpoint of PASI 100 at week 16.
“ORKA-002 has the opportunity to become the best antibody in the IL-17 class, which is preferred when treating psoriasis with joint involvement or recalcitrant skin disease, as well as psoriatic arthritis, hidradenitis suppurativa, and beyond,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “With this program now in the clinic, we are one step closer to our goal of offering the most possible freedom from disease to patients with psoriasis and other conditions.”
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 per 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-001 and ORKA-002, including timelines to clinical and data release milestones, the details of its clinical studies and the potential half-life of ORKA-001 and ORKA-002 and their potential dosing intervals. 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, its Quarterly Reports on Form 10-Q 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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