Oruka Therapeutics begins trial for psoriasis treatment

Published 20/05/2025, 21:10
Oruka Therapeutics begins trial for psoriasis treatment

MENLO PARK, Calif. - Oruka Therapeutics, Inc. (NASDAQ:ORKA), a biotech firm focusing on chronic skin diseases, has commenced a clinical trial involving healthy volunteers for its new drug, ORKA-002. The treatment is a monoclonal antibody targeting IL-17A and IL-17F, potentially offering less frequent dosing for psoriasis patients. With a market capitalization of $398 million, Oruka maintains a strong liquidity position, holding more cash than debt on its balance sheet. According to InvestingPro data, the company’s current ratio of 30.03 indicates robust short-term financial stability.

The Phase 1 trial is double-blind and placebo-controlled, testing the safety, tolerability, and pharmacokinetics of ORKA-002 across three subcutaneous dose cohorts. Approximately 24 participants are expected to partake in this study, with interim data projected to be released around the end of 2025. The company’s stock, currently trading at $10.65, has experienced significant volatility, declining over 53% in the past six months. InvestingPro subscribers can access 8 additional key insights about Oruka’s financial health and market position.

ORKA-002 is designed to be administered subcutaneously and has shown the potential to be dosed only two to three times a year, a significant reduction compared to current monthly treatments. This advancement could position ORKA-002 as a leading therapy in the IL-17 class, preferred for psoriasis with joint involvement and other recalcitrant skin diseases.

Pending the Phase 1 trial results, Oruka plans to initiate a Phase 2 study in the first half of 2026, focusing on moderate-to-severe psoriasis. This next study aims to evaluate the efficacy and safety of ORKA-002, with the primary endpoint being complete skin clearance at week 16.

According to Joana Goncalves, Chief Medical Officer of Oruka, ORKA-002 has the potential to significantly improve the quality of life for patients by offering more freedom from disease with less frequent dosing. Analysts maintain a bullish outlook on the company, with price targets ranging from $15 to $47, despite expectations of continued losses this year. Get deeper insights into Oruka’s financial metrics and growth potential with a InvestingPro subscription.

Oruka Therapeutics continues to develop a portfolio of antibodies targeting the core mechanisms underlying plaque psoriasis and other inflammatory diseases, aiming to achieve high rates of disease clearance with minimal dosing.

This news is based on a press release statement and includes forward-looking statements subject to risks and uncertainties. The information presented is not an endorsement of the company’s claims and should be viewed as potential developments that may or may not materialize.

In other recent news, Oruka Therapeutics has received attention following its fourth-quarter update for 2024. The company is financially robust, with approximately $394 million in cash and equivalents, ensuring a financial runway through 2027. Analysts from Stifel have maintained a Buy rating on Oruka Therapeutics, with a price target of $49, highlighting the company’s strategic position in the psoriasis market. Oruka’s ORKA-001 product, an IL-23p19 inhibitor, is on track, with Phase 1 human data expected in the second half of 2025. Additionally, Phase 2 data on psoriasis is projected for the second half of 2026, aiming to confirm the drug’s efficacy.

Oruka is also advancing its ORKA-002 compound, targeting IL-17A/F, with preclinical data presented at a recent dermatology meeting. Phase 1 trials for ORKA-002 are anticipated to begin in the third quarter of 2025, with pharmacokinetic data expected in the first half of 2026. The company is developing ORKA-021, a sequential regimen combining ’001’ and ’002’, to enhance symptom relief and offer improved maintenance dosing. These developments underscore Oruka Therapeutics’ continued focus on innovation in psoriasis treatment.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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