ORKA-002 / Oruka Therapeutics - LARVOL DELTA

ORKA-002: Phase 2 Trials in Plaque Psoriasis and Hidradenitis Suppurativa (GlobeNewswire) - "ORCA-SURGE, a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 trial designed to evaluate the safety and efficacy of ORKA-002 in moderate-to-severe PsO patients, is expected to commence in the first half of 2026...Maintenance dosing will evaluate the potential for twice-yearly dosing with ORKA-002. Data from ORCA-SURGE is anticipated in 2027...In addition, the Company expects to initiate a Phase 2 trial of ORKA-002 in HS patients in the second half of 2026."

New P2 trial • P2 data • Hidradenitis Suppurativa • Psoriasis

Interim results from the trial as of the January 2026 data cutoff are as follows, and additional data will be presented at an upcoming medical meeting. (GlobeNewswire) - "PK: ORKA-002 showed a half-life of 75-80 days, greater than three times that of bimekizumab, and a comparable Cmax to bimekizumab at equivalent doses based on previously reported bimekizumab data. Pharmacokinetic modeling based on these results supports achieving twice-yearly maintenance dosing in PsO and quarterly maintenance dosing in HS...In an ex vivo IL-17 stimulation assay, ORKA-002 was shown to potently inhibit IL-17 signaling at all dose levels through last follow-up (up to 24 weeks), further supporting the potential for twice-yearly dosing....ORKA-002 was well tolerated at all dose levels, with a favorable safety profile consistent with the anti-IL-17 class."

P1 data • PK/PD data • Hidradenitis Suppurativa • Psoriasis

Characterization of ORKA-002, a Novel Extended Half-life Monoclonal Antibody Targeting IL-17A/F for the Treatment of Psoriasis and Other Indications (ISDS 2025) - "Recently, a biologic targeting both IL-17A and IL-17F, bimekizumab (BIME), has demonstrated high efficacy that exceeds therapies targeting IL-17A only. ORKA-002 exhibits high selectivity and affinity for IL-17A and IL-17F in vitro, potent inhibition of downstream cellular signaling ex vivo, and an extended half-life in non-human primates compared to BIME. These characteristics could result in comparable or increased efficacy compared to BIME with just two to three doses of ORKA-002 a year. Clinical studies are planned to explore this potential."

Dermatology • Immunology • Psoriasis • IL17A • IL6

The Phase 1 trial of ORKA-002 is ongoing (GlobeNewswire) - "The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and PK of ORKA-002 in approximately 24 healthy volunteers. The Company expects to share interim data from this trial, including initial PK data, around YE 2025."

P1 data • Trial status • Psoriasis

The Company intends to begin a Phase 2 trial of ORKA-002 in moderate-to-severe PsO in 1H 2026 (GlobeNewswire) - "The Company also is planning for a Phase 2 trial in hidradenitis suppurativa (HS), which is included in cash runway forecasts."

New P2 trial • Hidradenitis Suppurativa • Psoriasis

Additional…updates (GlobeNewswire) - "The Company completed a $180M PIPE financing, extending runway over one year past three Phase 2 catalysts: the ORKA-001 Phase 2a and 2b studies (EVERLAST-A and -B), and the ORKA-002 Phase 2 study in PsO."

Financing • Psoriasis

Additional programs… (GlobeNewswire) - "(i) ORKA-021 (ORKA-002 → ORKA-001): Oruka continues to advance a sequential combination regimen of ORKA-002 and ORKA-001, which could deliver rapid and deep responses with an ideal maintenance profile. ORKA-021 could create another opportunity for the Company to define the best possible regimen for the treatment of psoriatic disease; (ii) ORKA-003: The Company continues to progress ORKA-003 through preclinical development."

Pipeline update • Psoriasis

Characterization of ORKA-002, a Novel Extended Half-life Monoclonal Antibody Targeting IL-17A/F for the Treatment of Psoriasis and Other Indications (ACR Convergence 2025) - "Recently, a biologic targeting both IL-17A and IL-17F, bimekizumab (BIME), has demonstrated high efficacy that exceeds therapies targeting IL-17A only. ORKA-002 exhibits high selectivity and affinity for IL-17A and IL-17F in vitro, potent inhibition of downstream cellular signaling ex vivo, and an extended half-life in non-human primates compared to BIME. These characteristics could result in comparable or increased efficacy compared to BIME with just two to three doses of ORKA-002 a year. Pre-clinical evidence for ORKA-002 reported here may lead to therapeutic improvements for psoriatic disease and other inflammatory conditions amenable to IL-17 inhibition."

Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A • IL6

ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Oruka Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human

Characterization of ORKA-002, a Novel Extended Half-life Monoclonal Antibody Targeting IL-17A/F for the Treatment of Psoriasis and Other Indications (EADV 2025) - "Recently, a biologic targeting both IL-17A and IL-17F, bimekizumab (BIME), has demonstrated high efficacy that exceeds therapies targeting IL-17A only. ORKA-002 exhibits high selectivity and affinity for IL-17A and IL-17F in vitro, potent inhibition of downstream cellular signaling ex vivo, and an extended half-life in non-human primates compared to BIME. These characteristics could result in comparable or increased efficacy compared to BIME with just two to three doses of ORKA-002 a year. Pre-clinical evidence for ORKA-002 reported here may lead to therapeutic improvements for psoriatic disease and other inflammatory conditions amenable to IL-17 inhibition."

Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A • IL6

ORKA-002: a novel half-life extended IL-17A/F monoclonal antibody (GlobeNewswire) - "The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and PK of ORKA-002 in approximately 24 healthy volunteers. The Company expects to share interim data from this trial, including initial PK data, around YE 2025, and to initiate a Phase 2 trial in psoriasis in 1H 2026."

New P2 trial • P1 data • Immunology • Psoriasis

Characterization of ORKA-002, a Novel Extended Half-life Monoclonal Antibody Targeting IL-17A/F for the Treatment of Psoriasis and Psoriatic Arthritis (EULAR 2025) - "Recently, a biologic molecule targeting both IL-17A and IL-17F, bimekizumab (BIME), has demonstrated high efficacy that exceeds therapies targeting IL-17A only. ORKA-002 exhibits high selectivity and affinity for IL-17A and IL-17F in vitro , potent inhibition of downstream cellular signaling ex vivo , and an extended half-life in non-human primates compared to BIME, providing the potential for comparable or increased efficacy compared with BIME combined with dosing every four to six months. Pre-clinical evidence for ORKA-002 reported here may lead to therapeutic improvements for psoriasis, psoriatic arthritis, and other inflammatory conditions amenable to IL-17 inhibition. Clinical studies are planned to explore this potential."

Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A • IL6

ORKA-002, a novel extended half-life monoclonal antibody targeting IL-17A/F for the treatment of psoriatic disease (SID 2025) - "Pre-clinical evidence for ORKA-002 reported here may lead to therapeutic improvements for psoriatic disease and other inflammatory conditions amenable to IL-17 inhibition. Clinical studies are planned to explore this potential."

Immunology • IL17A • IL6

ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Oruka Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Oruka Therapeutics Announces First Participants Dosed in Phase 1 Trial of ORKA-002, its Novel Half-life Extended Anti-IL-17A/F Antibody (GlobeNewswire) - "Oruka Therapeutics...announced that it has initiated dosing of healthy volunteers in its first clinical trial of ORKA-002, the Company’s novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A and IL-17F (IL-17A/F)....The ORKA-002 Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of ORKA-002 in approximately 24 healthy volunteers across three subcutaneous dose cohorts. Oruka expects to share interim data from this study around year end 2025....Oruka plans to initiate a Phase 2 study of ORKA-002 in moderate-to-severe psoriasis in the first half of 2026. The planned study design will evaluate the safety and efficacy of multiple dose levels and regimens of ORKA-002, with a primary endpoint of PASI 100 at week 16."

New P2 trial • P1 data • Trial status • Psoriasis

ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Oruka Therapeutics, Inc.

New P1 trial

Oruka Therapeutics Announces Preclinical Data for ORKA-002 at the 2025 American Academy of Dermatology Annual Meeting (GlobeNewswire) - "First subject dosed with ORKA-002 expected in Q3 2025...Projections of ORKA-002 pharmacokinetics (PK) in humans indicate that a human half-life of approximately 50 days could enable dosing once every four months, while a human half-life of approximately 75 days could enable twice-yearly dosing...ORKA-002 binds IL-17A and IL-17F with a comparable picomolar affinity as bimekizumab. Based on cryo-EM structural analysis, ORKA-002 binds to a nearly identical epitope to bimekizumab on both IL-17A and IL-17F. When assessed across multiple different assays in cell lines and primary cells, ORKA-002 also had comparable functional potency for IL-17A and IL-17F antagonism."

New trial • Preclinical • Psoriasis • Psoriatic Arthritis

Oruka Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Oruka plans to initiate a Phase 1 trial of ORKA-002 in the third quarter of 2025. The Company expects to share interim data from the first-in-human trial in healthy volunteers, including initial PK data, in the first half of 2026. Preclinical data on ORKA-002 will be presented at the American Academy of Dermatology (AAD) Annual Meeting this month.....Title: #64919 Characterization of ORKA-002, a Novel Extended Half-Life Monoclonal Antibody Targeting IL-17A/F for the Treatment of Psoriasis and Other Indications; Presentation Information: 8:30am ET, Friday, March 7, 2025."

New P1 trial • Preclinical • Psoriasis

Characterization of ORKA-002, a Novel Extended Half-life Monoclonal Antibody Targeting IL-17A/F for the Treatment of Psoriasis and Other Indications (AAD 2025) - "Recently, a biologic targeting both IL-17A and IL-17F, bimekizumab (BIME), has demonstrated high efficacy that exceeds therapies targeting IL-17A only. Pre-clinical evidence for ORKA-002 reported here may lead to therapeutic improvements for psoriatic disease and other inflammatory conditions amenable to IL-17 inhibition. Clinical studies are planned to explore this potential."

Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A • IL6