Oruka Therapeutics Announces First Participants Dosed in Phase 1 Trial of ORKA-001, its Novel Half-life Extended Anti-IL-23p19 Antibody
Oruka Therapeutics (ORKA) has begun dosing healthy volunteers in its Phase 1 trial of ORKA-001, a novel half-life extended monoclonal antibody targeting IL-23p19 for treating chronic skin diseases. The trial will evaluate safety, tolerability, and pharmacokinetics in approximately 24 healthy volunteers across three subcutaneous dose cohorts.
Initial data is expected in H2 2025, followed by a proof-of-concept study in moderate-to-severe psoriasis. The subsequent study will involve about 80 subjects testing six-month and potential yearly dosing schedules, with initial efficacy data anticipated in H2 2026.
Preclinical data suggests potential for once- or twice-yearly dosing, representing a significant improvement over current standards. The company has also secured a worldwide exclusive license agreement with Paragon Therapeutics for ORKA-001 in all indications except inflammatory bowel disease.
Oruka Therapeutics (ORKA) ha iniziato a somministrare dosi a volontari sani nel suo studio di Fase 1 per ORKA-001, un nuovo anticorpo monoclonale con prolungata emivita che mira a IL-23p19 per il trattamento delle malattie cutanee croniche. Lo studio valuterà sicurezza, tollerabilità e farmacocinetica in circa 24 volontari sani suddivisi in tre coorti di dosaggio sottocutaneo.
I dati iniziali sono attesi nel secondo semestre del 2025, seguiti da uno studio di prova di concetto per la psoriasi da moderata a grave. Lo studio successivo coinvolgerà circa 80 soggetti e testerà schemi di dosaggio semestrale e potenzialmente annuale, con dati iniziali sull'efficacia previsti per il secondo semestre del 2026.
I dati preclinici suggeriscono un potenziale per dosaggi una o due volte l'anno, rappresentando un miglioramento significativo rispetto agli standard attuali. L'azienda ha inoltre ottenuto un accordo di licenza esclusiva mondiale con Paragon Therapeutics per ORKA-001 in tutte le indicazioni tranne che per la malattia infiammatoria intestinale.
Oruka Therapeutics (ORKA) ha comenzado a administrar dosis a voluntarios sanos en su ensayo de Fase 1 para ORKA-001, un novedoso anticuerpo monoclonal con una vida media prolongada que tiene como objetivo IL-23p19 para tratar enfermedades crónicas de la piel. El ensayo evaluará la seguridad, la tolerabilidad y la farmacocinética en aproximadamente 24 voluntarios sanos distribuidos en tres cohortes de dosis subcutáneas.
Se espera que los datos iniciales estén disponibles en el segundo semestre de 2025, seguidos de un estudio de prueba de concepto en psoriasis moderada a grave. El estudio posterior implicará a aproximadamente 80 sujetos que probarán esquemas de dosificación de seis meses y potencialmente anuales, con datos iniciales de eficacia anticipados para el segundo semestre de 2026.
Los datos preclínicos sugieren un potencial para dosificaciones una o dos veces al año, representando una mejora significativa sobre los estándares actuales. La empresa también ha asegurado un acuerdo de licencia exclusiva mundial con Paragon Therapeutics para ORKA-001 en todas las indicaciones excepto la enfermedad inflamatoria intestinal.
오루카 치료제 (ORKA)는 만성 피부 질환 치료를 위해 IL-23p19를 표적으로 하는 새로운 반감기 연장 모노클로날 항체인 ORKA-001의 1상 시험에서 건강한 자원봉사자들에게 약물 투여를 시작했습니다. 이번 시험은 약 24명의 건강한 자원봉사자를 대상으로 세 가지 피하 용량 집단에서 안전성, 내약성 및 약물 동태를 평가할 것입니다.
초기 데이터는 2025년 하반기에 예상되며, 그 후 중등도에서 중증의 건선에 대한 개념 증명 연구가 진행될 예정입니다. 후속 연구에는 약 80명이 참여하며, 6개월 및 잠재적인 연간 투여 계획을 검토하며, 초기 효능 데이터는 2026년 하반기에 기대됩니다.
전임상 데이터는 연간 1회 또는 2회 투여의 가능성을 제시하며, 현재 기준에 비해 상당한 개선을 나타냅니다. 이 회사는 또한 염증성 장 질환을 제외한 모든 적응증에 대해 ORKA-001에 대한 Paragon Therapeutics와 전 세계 독점 라이선스 계약을 체결했습니다.
Oruka Therapeutics (ORKA) a commencé à administrer des doses à des volontaires en bonne santé dans son essai de Phase 1 pour ORKA-001, un nouvel anticorps monoclonal à demi-vie prolongée ciblant IL-23p19 pour le traitement des maladies cutanées chroniques. L'essai évaluera la sécurité, la tolérabilité et la pharmacocinétique chez environ 24 volontaires sains répartis en trois cohortes de doses sous-cutanées.
Les premières données sont attendues au second semestre 2025, suivies d'une étude de faisabilité sur le psoriasis modéré à sévère. L'étude suivante impliquera environ 80 sujets testant des schémas posologiques de six mois et potentiellement annuels, avec des données préliminaires d'efficacité anticipées au second semestre 2026.
Les données précliniques suggèrent un potentiel pour une posologie annuelle ou semestrielle, représentant une amélioration significative par rapport aux normes actuelles. L'entreprise a également obtenu un accord de licence exclusive mondial avec Paragon Therapeutics pour ORKA-001 dans toutes les indications sauf les maladies inflammatoires de l'intestin.
Oruka Therapeutics (ORKA) hat mit der Verabreichung von Dosen an gesunde Freiwillige in seiner Phase-1-Studie für ORKA-001 begonnen, einem neuartigen, lebensverlängerten monoklonalen Antikörper, der auf IL-23p19 abzielt, um chronische Hautkrankheiten zu behandeln. Die Studie wird Sicherheit, Verträglichkeit und Pharmakokinetik bei etwa 24 gesunden Freiwilligen in drei subkutanen Dosierungsgruppen bewerten.
Erste Daten werden im 2. Halbjahr 2025 erwartet, gefolgt von einer Machbarkeitsstudie zur mittelgradigen bis schweren Psoriasis. Die nachfolgende Studie wird etwa 80 Probanden einbeziehen, die Dosispläne über sechs Monate und möglicherweise jährlich testen, wobei erste Wirksamkeitsdaten im 2. Halbjahr 2026 erwartet werden.
Präklinische Daten deuten auf ein Potenzial für einmal oder zweimal jährlich Dosierungen hin, was eine signifikante Verbesserung gegenüber den aktuellen Standards darstellt. Das Unternehmen hat außerdem eine weltweite exklusive Lizenzvereinbarung mit Paragon Therapeutics für ORKA-001 in allen Indikationen, ausgenommen Entzündliche Darmerkrankungen, gesichert.
- Phase 1 trial initiated ahead of schedule
- Preclinical data indicates potential for once- or twice-yearly dosing versus current more frequent treatments
- Secured worldwide exclusive licensing rights for multiple indications
- Clear development timeline with multiple data readouts in 2025-2026
- Initial efficacy data not available until H2 2026
- to small sample size of 24 volunteers in Phase 1
- Excluded from inflammatory bowel disease indications in licensing agreement
Insights
The initiation of ORKA-001's Phase 1 trial represents a strategic advancement in Oruka's pipeline development. The antibody's novel half-life extension technology targeting IL-23p19 could revolutionize psoriasis treatment by significantly reducing dosing frequency from current bi-monthly or quarterly injections to annual or semi-annual administration. Preclinical data suggesting once or twice-yearly dosing positions ORKA-001 as a potential market disruptor in the
The trial design is robust - a double-blind, placebo-controlled study with 24 subjects across three dose cohorts provides sufficient statistical power for initial safety and PK assessment. The planned proof-of-concept study's innovative design, particularly the maintenance arm evaluation, could validate the extended dosing hypothesis. The exclusive licensing deal with Paragon Therapeutics expands the commercial potential beyond inflammatory bowel disease, creating multiple revenue streams.
The IL-23p19 targeting approach has proven highly effective in psoriasis treatment, as demonstrated by competitors like Skyrizi and Tremfya. However, ORKA-001's potential differentiator lies in its half-life extension technology. Current biologics require 8-12 week dosing intervals, creating a significant burden on patients. A successful transition to annual dosing would represent a paradigm shift in chronic disease management.
The trial's inclusion of a maintenance arm specifically designed to assess duration of skin clearance is particularly noteworthy. This could provide important data on the drug's real-world effectiveness and potentially support ultra-long dosing intervals. The 80-patient proof-of-concept study scheduled for late 2025 is well-designed to demonstrate both efficacy and the revolutionary dosing schedule.
With a market cap of
The licensing agreement with Paragon Therapeutics is strategically important, as it allows Oruka to maintain focus on dermatology while monetizing other potential indications. Key catalysts include interim Phase 1 data in H2 2025 and initial proof-of-concept results in H2 2026, which could drive substantial value creation if positive. The company's ahead-of-schedule execution on clinical development is encouraging for meeting these timelines.
Pharmacokinetic and safety data from healthy volunteers anticipated in the second half of 2025
On track to initiate a proof-of-concept study in psoriasis in the second half of 2025, with initial efficacy data expected in the second half of 2026
Preclinical data with ORKA-001 demonstrate the potential for once- or twice-yearly dosing, a significant improvement over standard of care
MENLO PARK, Calif., Dec. 19, 2024 (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-001, the Company’s novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19.
“The initiation of this Phase 1 study of ORKA-001 marks an important milestone for Oruka, which our team has delivered ahead of schedule,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We look forward to sharing initial data for ORKA-001 in the second half of 2025, which could validate ORKA-001’s half-life and safety profile, supporting extended dosing intervals and best-in-class potential.”
The ORKA-001 Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of ORKA-001 in healthy volunteers. The study is expected to enroll approximately 24 healthy volunteers across three subcutaneous dose cohorts. Oruka expects to share interim data from this study in the second half of 2025.
Pending data from the Phase 1 trial, Oruka plans to initiate a proof-of-concept study of ORKA-001 in moderate-to-severe psoriasis in the second half of 2025. This study is anticipated to evaluate the safety and efficacy of a single dose level of ORKA-001 versus placebo in approximately 80 subjects, followed by randomization to one of two maintenance dosing arms. In one maintenance arm, subjects will receive ORKA-001 every six months. In the other, subjects will receive only induction dosing to assess the length of time patients maintain clear skin, which could support once-yearly dosing or even longer-term durability in some patients. Subjects then can continue to an open-label extension study. The company expects to share initial data from the proof-of concept study in the second half of 2026.
“We believe that ORKA-001 has the potential to set a new standard in the treatment of plaque psoriasis in terms of both depth and duration of response,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “We hear consistently that people with psoriasis want to achieve freedom from their disease, and that is what we hope to offer with this program. The initiation of this Phase 1 study brings us one step closer to that goal.”
Additionally, the Company announced that it has entered into a license agreement with Paragon Therapeutics granting it worldwide exclusive rights to ORKA-001 in all indications other than inflammatory bowel disease.
About ORKA-001
ORKA-001 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe PsO given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance. Data from studies in non-human primates and other preclinical assays show that ORKA-001 binds to a similar epitope with similar affinity as risankizumab and has a significantly extended half-life over three times longer than risankizumab.
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, including timelines to clinical and data release milestones, the details of its proof of concept study and the potential half-life of ORKA-001 and its potential dosing interval. 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 registration statement on Form S-1 and its Quarterly Reports on Form 10-Q. 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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