Oruka Therapeutics Announces Accelerated Clinical Timelines and Upcoming Presentation at EADV Supporting ORKA-001’s Profile as a Potentially Best-in-Class Half-Life Extended Antibody Targeting IL-23p19
Oruka Therapeutics (Nasdaq: ORKA) has announced accelerated timelines for its novel biologics targeting chronic skin diseases. ORKA-001, a half-life extended antibody targeting IL-23p19, is now expected to start first-in-human dosing in Q1 2025. ORKA-002, targeting IL-17A/F, is set for first-in-human dosing in Q3 2025.
ORKA-001 shows potential for once or twice yearly dosing, with higher exposures than current IL-23p19 antibodies, potentially leading to higher disease clearance rates. Preclinical data, including a half-life of over 30 days in non-human primates, will be presented at the European Academy of Dermatology and Venereology Congress (EADV) in September.
Interim data for ORKA-001 in healthy volunteers is expected in H2 2025, with initial efficacy data in psoriasis patients in H2 2026. For ORKA-002, interim data from healthy volunteers is anticipated in H1 2026.
Oruka Therapeutics (Nasdaq: ORKA) ha annunciato tempistiche accelerate per i suoi nuovi biologici destinati a malattie croniche della pelle. ORKA-001, un anticorpo a emivita estesa che colpisce l'IL-23p19, è ora previsto per l'inizio della somministrazione negli esseri umani nel primo trimestre del 2025. ORKA-002, che agisce sull'IL-17A/F, è programmato per il primo dosaggio negli esseri umani nel terzo trimestre del 2025.
ORKA-001 mostra potenziale per somministrazioni una o due volte all'anno, con esposizioni maggiori rispetto agli attuali anticorpi per l'IL-23p19, il che potrebbe portare a tassi di guarigione più elevati. I dati preclinici, che includono un'emivita di oltre 30 giorni in primati non umani, saranno presentati al Congresso dell'Accademia Europea di Dermatologia e Venereologia (EADV) a settembre.
I dati temporanei per ORKA-001 in volontari sani sono attesi nella seconda metà del 2025, con dati sull'efficacia iniziali in pazienti affetti da psoriasi nella seconda metà del 2026. Per ORKA-002, i dati provvisori da volontari sani sono previsti per la prima metà del 2026.
Oruka Therapeutics (Nasdaq: ORKA) ha anunciado cronogramas acelerados para sus nuevos biológicos dirigidos a enfermedades crónicas de la piel. ORKA-001, un anticuerpo de vida media extendida que se dirige a IL-23p19, ahora se espera que comience la dosificación en humanos en el primer trimestre de 2025. ORKA-002, que se dirige a IL-17A/F, está programado para la primera dosificación en humanos en el tercer trimestre de 2025.
ORKA-001 muestra potencial para dosificaciones una o dos veces al año, con mayores exposiciones que los actuales anticuerpos de IL-23p19, lo que podría llevar a tasas de aclaramiento de enfermedades más altas. Los datos preclínicos, que incluyen una vida media de más de 30 días en primates no humanos, se presentarán en el Congreso de la Academia Europea de Dermatología y Venereología (EADV) en septiembre.
Se esperan datos interinos para ORKA-001 en voluntarios sanos en la segunda mitad de 2025, con datos iniciales de eficacia en pacientes con psoriasis en la segunda mitad de 2026. Para ORKA-002, se anticipan datos interinos de voluntarios sanos en la primera mitad de 2026.
Oruka Therapeutics (Nasdaq: ORKA)가 만성 피부 질환을 겨냥한 새로운 생물학적 제제의 발전된 일정을 발표했습니다. ORKA-001, IL-23p19를 표적하는 반감기 연장 항체는 2025년 1분기에 사람에게 첫 투여가 시작될 것으로 예상됩니다. ORKA-002, IL-17A/F를 목표로 하는 이는 2025년 3분기에 첫 투여가 예정되어 있습니다.
ORKA-001은 연 1회 또는 2회 투여의 가능성을 나타내며, 현재 IL-23p19 항체보다 높은 노출량으로 질병 제거율이 더 높을 수 있습니다. 비인간 영장류에서 30일 이상의 반감기를 포함하는 전임상 데이터는 9월에 열리는 유럽 피부과 및 성병학 아카데미(EADV) Congress에서 발표될 예정입니다.
건강한 자원자에 대한 ORKA-001의 중간 데이터는 2025년 하반기에 예상되며, 건선 환자에 대한 초기 효능 데이터는 2026년 하반기에 예상됩니다. ORKA-002에 대한 건강한 자원자의 중간 데이터는 2026년 상반기에 예상됩니다.
Oruka Therapeutics (Nasdaq: ORKA) a annoncé des délais accélérés pour ses nouveaux biologiques ciblant les maladies chroniques de la peau. ORKA-001, un anticorps à demi-vie prolongée ciblant l'IL-23p19, devrait maintenant commencer la première administration chez l'homme au premier trimestre 2025. ORKA-002, ciblant l'IL-17A/F, est prévu pour une administration chez l'homme au troisième trimestre 2025.
ORKA-001 montre un potentiel pour une administration annuelle ou bisannuelle, avec des expositions plus élevées que les anticorps actuels contre l'IL-23p19, ce qui pourrait entraîner des taux d'élimination des maladies plus élevés. Des données précliniques, y compris une demi-vie de plus de 30 jours chez des primates non humains, seront présentées lors du Congrès de l'Académie Européenne de Dermatologie et de Vénéréologie (EADV) en septembre.
Des données intermédiaires pour ORKA-001 chez des volontaires en bonne santé sont attendues au second semestre 2025, avec des données d'efficacité initiales chez des patients atteints de psoriasis au second semestre 2026. Pour ORKA-002, des données intermédiaires de volontaires sains sont anticipées pour le premier semestre 2026.
Oruka Therapeutics (Nasdaq: ORKA) hat beschleunigte Zeitpläne für seine neuartigen Biologika zur Behandlung chronischer Hauterkrankungen bekannt gegeben. ORKA-001, ein Antikörper mit verlängertem Halbwertszeit, der auf IL-23p19 abzielt, soll nun im ersten Quartal 2025 mit der ersten menschlichen Dosierung beginnen. ORKA-002, welches IL-17A/F anspricht, ist für die erste Dosierung am Menschen im dritten Quartal 2025 geplant.
ORKA-001 zeigt Potenzial für eine jährliche oder halbjährliche Dosierung, mit höheren Expositionen als aktuelle IL-23p19-Antikörper, was möglicherweise zu höheren Heilungsraten führt. Vorläufige Daten, einschließlich einer Halbwertszeit von über 30 Tagen bei nicht-humanoiden Primaten, werden im September auf dem Kongress der Europäischen Akademie für Dermatologie und Venerologie (EADV) präsentiert.
Zwischenergebnisse für ORKA-001 bei gesunden Probanden werden für das zweite Halbjahr 2025 erwartet, mit ersten Wirksamkeitsdaten bei Psoriasis-Patienten im zweiten Halbjahr 2026. Für ORKA-002 werden Zwischenergebnisse von gesunden Probanden für das erste Halbjahr 2026 erwartet.
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ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody (mAb), first-in-human dosing now expected first quarter 2025
ORKA-002, a novel half-life extended IL-17A/F mAb, first-in-human dosing now expected third quarter 2025
New preclinical data on ORKA-001 to be presented at EADV in September showing robust preclinical activity including a half-life in NHPs of over 30 days
MENLO PARK, Calif., Sept. 12, 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 (PsO), today announced updated pipeline progress and timelines, as well as an upcoming scientific presentation at the European Academy of Dermatology and Venereology Congress (EADV).
- First-in-human dosing of ORKA-001 in healthy volunteers is now expected to start during the first quarter of 2025. ORKA-001 is a novel, subcutaneously (SQ) administered, half-life extended mAb 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. The company expects to share interim data from the first-in-human trial in healthy volunteers in the second half of 2025 and initial efficacy data in psoriasis patients in the second half of 2026.
- First-in-human dosing of ORKA-002 in healthy volunteers is now expected to start during the third quarter 2025. ORKA-002 is a novel, SQ administered, half-life extended mAb targeting IL-17A/F. Dual inhibition of IL-17A and F has resulted in high PASI 100 rates in PsO and is ideally suited to patients with concurrent psoriatic arthritis (PsA) or recalcitrant skin disease. IL-17A/F inhibition has also shown promising efficacy in other diseases such as hidradenitis suppurativa (HS) and axial spondyloarthritis (axSpA). ORKA-002 is designed to provide patients with a treatment option with substantially less frequent dosing, while offering similar disease clearance to established agents. The company expects to share interim data from the first-in-human trial in healthy volunteers in the first half of 2026.
- Oruka will present preclinical data on ORKA-001 for the first time at EADV. The presentation will include in vitro potency compared to benchmark antibodies and pharmacokinetics showing that ORKA-001 has a half-life of over 30 days in non-human primates (NHPs). This NHP half-life is toward the higher end of those observed for half-life extended antibodies and increases the likelihood that an improved human half-life will be observed, potentially enabling extended dose intervals with higher antibody exposures than established regimens.
“The Oruka team has worked incredibly hard to progress our programs towards the clinic, with our first drug candidate now expected to be in humans approximately a year from the Company’s inception,” said Lawrence Klein, Oruka’s Chief Executive Officer. “The excellent pharmacokinetic profile in NHPs supports our conviction that ORKA-001 could provide patients greater freedom from disease than currently available agents.”
Details of the presentation at EADV, September 25-28, 2024, in Amsterdam, Netherlands are as follows:
Characterization of ORKA-001, a Novel Extended Half-life Monoclonal Antibody Targeting IL-23 for the Treatment of Psoriasis
Abstract #4711, E-Poster #P3283
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 the expected timelines for first in human dosing and interim and initial efficacy data from such trials, the ultimate profile of products from each program and the potential of ORKA-001 and ORKA-002 to become best-in-class drugs. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. 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 (including its S-4 Registration Statement). 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. 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
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