ORKA-001 for psoriasis phase 2a

[Fred]

ORKA-001 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19 that has the potential to be dosed just once or twice a year in patients with psoriasis.

Quote:

---

Oruka Therapeutics 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 the U.S. FDA cleared its investigational new drug (IND) application for its Phase 2a trial of ORKA-001 (the Company’s long-acting anti-IL-23p19 antibody) in moderate-to-severe psoriasis, called EVERLAST-A.

“We’re thrilled by this rapid progress into Phase 2 development, and very excited to start our first psoriasis study,” said Lawrence Klein, PhD, CEO of Oruka. “We think that ORKA-001 can redefine the standard of care in this important disease with potential for once per year dosing, off-treatment remissions and higher rates of disease clearance.”

The U.S. FDA cleared the Company’s IND submission to initiate EVERLAST-A. EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a trial designed to evaluate the safety and efficacy of a single dose level of ORKA-001 in moderate-to-severe psoriasis patients. EVERLAST-A will enroll approximately 80 patients, randomized 3:1 to receive ORKA-001 or matching placebo. The primary endpoint is PASI 100 at Week 16. ORKA-001 exposures are expected to match or exceed exposures in the KNOCKOUT study, providing a definitive test of whether higher exposures of an anti-IL-23p19 antibody can lead to greater efficacy. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to either an arm where they do not receive another dose until disease recurs or ORKA-001 every six months. This “no-dose” arm will provide evidence for both yearly dosing and the potential for extended off-treatment remissions. Patients who have not yet achieved PASI 100 at Week 28 will receive ORKA-001 every six months.

"We have made great strides in our ability to treat psoriatic disease, but many patients are still seeking improved treatment options. I’m excited about EVERLAST-A and the potential that ORKA-001 could enable long dosing intervals and greater efficacy than current IL-23 inhibiting medications. There is evidence now that these improvements could be within reach, and they would be a significant step forward for both patients and the field,”

Source: orukatx.com

[Fred]

Update: Oruka Therapeutics Announces Positive Week 16 Data for ORKA-001 from the Ongoing EVERLAST-A Phase 2a Trial in Moderate-to-Severe Plaque Psoriasis

Quote:

---

Oruka Therapeutics today announced positive interim results from its EVERLAST-A Phase 2a trial of ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody, in moderate-to-severe plaque psoriasis.

“These data reached the top end of what we could have expected from ORKA-001 across efficacy, tolerability, and potential for long-lasting response,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “We’re thrilled with the profile that is emerging for this program and are excited to see how the data mature with longer-term follow-up. I want to thank the Oruka team, the EVERLAST-A investigators, and the trial participants for getting this study off to a tremendous start.”

“These data with ORKA-001 are highly compelling,” said Dr. Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine and lead investigator for EVERLAST-A. “If this type of efficacy and safety profile could be available with dosing once to twice per year, it would represent a major step forward for the field. I could envision this being the preferred product for any patient with moderate-to-severe psoriasis.”

EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a trial evaluating the safety, efficacy, and pharmacokinetics of ORKA-001 in participants with moderate-to-severe plaque psoriasis. The study is being conducted across 26 sites in the United States and Canada, and enrolled 84 patients randomized 3:1 to receive 600 mg of ORKA-001 at Week 0 and 4 or matching placebo. Baseline characteristics were comparable to recent studies in moderate-to-severe psoriasis.