Oruka Therapeutics Announces Positive Interim Phase 1 Results for ORKA-001
News Summary
Oruka Therapeutics announced positive interim Phase 1 trial results for ORKA-001, its long-acting IL-23p19 antibody for chronic skin diseases like plaque psoriasis. The drug demonstrated an impressive half-life of approximately 100 days, significantly exceeding risankizumab, and supporting the potential for once-per-year maintenance dosing. Pharmacokinetic data suggests ORKA-001 can achieve exposures comparable to studies showing best-in-class skin clearance and extended off-treatment remissions. ORKA-001 was well tolerated with a favorable safety profile consistent with the anti-IL-23 class across all dose levels, with no severe treatment-emergent adverse events. The company's ongoing EVERLAST-A Phase 2a trial aims to validate annual dosing, higher rates of skin clearance, and long-term off-treatment remissions. Oruka expects to present initial EVERLAST-A data in 2H 2026 and plans to initiate the EVERLAST-B Phase 2b dose-ranging trial in 1H 2026 to expedite development.
Background
Oruka Therapeutics is a biotechnology company focused on developing novel biologics designed to set a new standard for the treatment of chronic skin diseases such as plaque psoriasis. Its lead candidate, ORKA-001, is a novel monoclonal antibody targeting IL-23p19. IL-23p19 inhibitors have become the preferred first-line therapy for patients with moderate-to-severe plaque psoriasis due to their strong efficacy and safety profile. Currently approved IL-23p19 therapies are dosed four to six times per year and deliver PASI 100 (fully clear skin) for less than half of patients after four months. ORKA-001 is designed to be dosed just once or twice per year and to achieve higher exposures than currently marketed IL-23p19 antibodies, potentially leading to higher rates of disease clearance and extended off-treatment remissions, thereby addressing limitations of existing treatments.
In-Depth AI Insights
How does ORKA-001's ultra-long half-life redefine the IL-23p19 market and what are the potential competitive threats it poses? - ORKA-001's half-life of approximately 100 days, more than three times that of existing competitors like risankizumab, positions it for potential once-per-year dosing. This significantly enhances patient adherence and could reduce overall healthcare costs, offering a powerful market differentiator. - This innovation could compel existing market leaders to re-evaluate their R&D pipelines and invest more heavily in developing longer-acting alternatives to avoid market share erosion. - However, the promise of