Oruka Therapeutics (ORKA) said late Tuesday it has commenced dosing healthy volunteers in its phase 1 trial for ORKA-002, a novel, long-acting monoclonal antibody designed to target IL-17A/F for the treatment of chronic skin diseases.
The trial will assess the safety, tolerability, and pharmacokinetics of three subcutaneous dose levels in about 24 participants, the biotechnology company said, adding that preclinical data indicates that ORKA-002 may allow dosing just two to three times annually for psoriasis patients, representing a notable advancement over the current standard of care.
The company said it expects releasing interim data by the end of 2025 and aims to begin a phase 2 trial for moderate-to-severe psoriasis in the first half of 2026. The planned phase 2 study will evaluate various dose levels, with the primary endpoint being PASI 100 at week 16.
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