Oruka Therapeutics (ORKA) Status update summary

Program Overview and Clinical Strategy

• ORKA-001 and ORKA-002 are ultra-long-acting monoclonal antibodies targeting IL-23/p19 and IL-17A/F, aiming for annual or semi-annual dosing and superior efficacy in psoriatic disease.

• ORKA-001 is positioned for annual dosing in skin psoriasis, while ORKA-002 targets joint disease and hidradenitis suppurativa.

• Both programs are in phase II, with EVERLAST-A and EVERLAST-B for ORKA-001 and phase II for ORKA-002 in psoriasis, with HS trials planned.

• The psoriasis biologics market exceeds $31B, projected to reach $39B by 2030, with high demand for more effective, less frequent therapies.

EVERLAST-A Trial Design and Baseline

• EVERLAST-A is a double-blind, placebo-controlled phase II study with 84 participants, using a high induction dose of 600 mg at weeks 0 and 4.

• The trial uses stringent eligibility criteria and innovative design to assess off-treatment remission and annual dosing potential.

• Baseline characteristics were well balanced and comparable to prior psoriasis trials.

Efficacy and Safety Results

• At week 16, 63.5% of ORKA-001 patients achieved PASI 100 (complete skin clearance), significantly outperforming placebo (4.8%).

• High efficacy was also seen in PASI 90 (83%) and absolute PASI ≤1 (76%) at week 16.

• Efficacy was consistent across subgroups, including those with higher disease severity and prior biologic use.

• Safety profile was favorable, with similar adverse event rates to placebo, no serious adverse events, and most events being mild; upper respiratory tract infection was the most common.

• No injection site reactions or impact of anti-drug antibodies on PK were observed.