Pharmacokinetic and safety data from healthy volunteers anticipated around YE 2025
On track to initiate a Phase 2 study in 1H 2026
ORKA-002 preclinical data demonstrate the potential for dosing two to three times per year in psoriasis, a significant improvement over standard of care
MENLO PARK, CA, USA I May 20, 2025 I 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, today 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).
“With both ORKA-001 and ORKA-002 now in human trials, we are moving quickly to demonstrate the clinical differentiation of both assets,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Bimekizumab is launching extremely well as IL-17A/F has emerged as superior to IL-17A inhibition in several important indications. Uniquely, we could have the best targeting approaches for both IL-23p19 and IL-17A/F, potentially allowing us to offer the ideal regimen to patients through our ORKA-001 and -002 monotherapies and our ORKA-021 sequential combination.”
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.
Pending data from the Phase 1 trial, 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.
“ORKA-002 has the opportunity to become the best antibody in the IL-17 class, which is preferred when treating psoriasis with joint involvement or recalcitrant skin disease, as well as psoriatic arthritis, hidradenitis suppurativa, and beyond,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “With this program now in the clinic, we are one step closer to our goal of offering the most possible freedom from disease to patients with psoriasis and other conditions.”
About ORKA-002
ORKA-002 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A/F. Dual inhibition of both IL-17A and IL-17F has shown superior efficacy compared to IL-17A inhibition alone in psoriasis (PsO) and other indications, as shown by the performance of Bimzelx (bimekizumab) compared to Cosentyx (secukinumab) and Taltz (ixekizumab) in Phase 3 trials. These therapies all utilize monthly maintenance dosing in PsO and psoriatic arthritis (PsA), except Bimzelx in PsO patients weighing <120 kg, where Q8W maintenance dosing is recommended. In contrast, ORKA-002 has the potential to be dosed just two to three times per year in PsO and PsA, which we believe could allow ORKA-002 to become the leading therapy in the IL-17 class. Data from studies in non-human primates and other preclinical assays show that ORKA-002 binds to a similar epitope with similar affinity as bimekizumab and has a significantly extended half-life over three times longer than bimekizumab.
About Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.
SOURCE: Oruka Therapeutics
Post Views: 1,807
Pharmacokinetic and safety data from healthy volunteers anticipated around YE 2025
On track to initiate a Phase 2 study in 1H 2026
ORKA-002 preclinical data demonstrate the potential for dosing two to three times per year in psoriasis, a significant improvement over standard of care
MENLO PARK, CA, USA I May 20, 2025 I 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, today 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).
“With both ORKA-001 and ORKA-002 now in human trials, we are moving quickly to demonstrate the clinical differentiation of both assets,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Bimekizumab is launching extremely well as IL-17A/F has emerged as superior to IL-17A inhibition in several important indications. Uniquely, we could have the best targeting approaches for both IL-23p19 and IL-17A/F, potentially allowing us to offer the ideal regimen to patients through our ORKA-001 and -002 monotherapies and our ORKA-021 sequential combination.”
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.
Pending data from the Phase 1 trial, 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.
“ORKA-002 has the opportunity to become the best antibody in the IL-17 class, which is preferred when treating psoriasis with joint involvement or recalcitrant skin disease, as well as psoriatic arthritis, hidradenitis suppurativa, and beyond,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “With this program now in the clinic, we are one step closer to our goal of offering the most possible freedom from disease to patients with psoriasis and other conditions.”
About ORKA-002
ORKA-002 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A/F. Dual inhibition of both IL-17A and IL-17F has shown superior efficacy compared to IL-17A inhibition alone in psoriasis (PsO) and other indications, as shown by the performance of Bimzelx (bimekizumab) compared to Cosentyx (secukinumab) and Taltz (ixekizumab) in Phase 3 trials. These therapies all utilize monthly maintenance dosing in PsO and psoriatic arthritis (PsA), except Bimzelx in PsO patients weighing <120 kg, where Q8W maintenance dosing is recommended. In contrast, ORKA-002 has the potential to be dosed just two to three times per year in PsO and PsA, which we believe could allow ORKA-002 to become the leading therapy in the IL-17 class. Data from studies in non-human primates and other preclinical assays show that ORKA-002 binds to a similar epitope with similar affinity as bimekizumab and has a significantly extended half-life over three times longer than bimekizumab.
About Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.
SOURCE: Oruka Therapeutics
Post Views: 1,807
