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

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

Excerpt from the Press Release:

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.

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