StockNews.AI

Oruka Therapeutics Announces Positive Interim Phase 1 Data for ORKA-002 and Initiation of EVERLAST-B Trial of ORKA-001

StockNews.AI • 13 hours

BIMEPFEJNJ
High Materiality8/10

Information

ORKA-002 interim Phase 1 data demonstrates a half-life of 75-80 days supporting potential for twice-...

Original source

AI Summary

ORKA-002 shows a half-life of 75-80 days, supporting infrequent dosing. Phase 2 trials for ORKA-002 start in 2026, boosting potential market impact. Positive interim data increases confidence in ORKA-001's effectiveness in psoriasis. No severe adverse effects reported in ORKA-002 trial, indicating safety. Novel biologics may set new treatment standards for chronic skin diseases.

Sentiment Rationale

The positive early data for ORKA-002 suggests strong market potential. Historical cases show that successful trials often lead to significant stock price increases.

Trading Thesis

With Phase 2 trials set to begin in 2026, results could take time to affect ORKA's long-term valuation. Successful outcomes in pivotal trials typically enhance investor confidence over time.

Market-Moving

  • ORKA-002 shows a half-life of 75-80 days, supporting infrequent dosing.
  • Phase 2 trials for ORKA-002 start in 2026, boosting potential market impact.
  • Positive interim data increases confidence in ORKA-001's effectiveness in psoriasis.

Key Facts

  • ORKA-002 shows a half-life of 75-80 days, supporting infrequent dosing.
  • Phase 2 trials for ORKA-002 start in 2026, boosting potential market impact.
  • Positive interim data increases confidence in ORKA-001's effectiveness in psoriasis.
  • No severe adverse effects reported in ORKA-002 trial, indicating safety.
  • Novel biologics may set new treatment standards for chronic skin diseases.

Companies Mentioned

  • BIME (BIME)
  • PFE (PFE)
  • JNJ (JNJ)

Research Analysis

The article outlines significant progress in ORKA's research pipeline, indicating growth potential. Positive clinical results can increase market interest.

Oruka Therapeutics Shares Encouraging Interim Phase 1 Results for ORKA-002 and Launches EVERLAST-B Trial for ORKA-001

January 12, 2026 - Menlo Park, California

Oruka Therapeutics, Inc. (Nasdaq: ORKA), a pioneering biotechnology company, has announced positive interim data from its Phase 1 trial of ORKA-002, alongside updates from ongoing trials for ORKA-001.

Phase 1 Results for ORKA-002

The interim data from the ORKA-002 trial indicates a significant half-life of 75-80 days, suggesting the potential for both twice-per-year dosing in plaque psoriasis (PsO) and quarterly dosing in hidradenitis suppurativa (HS).

Lawrence Klein, PhD, CEO of Oruka, expressed enthusiasm about the trial's progress: “We’re thrilled with the rapid advances of both ORKA-001 and ORKA-002. This data reinforces our belief in their potential impact on psoriatic disease treatments.”

Details from the ORKA-002 Phase 1 Trial

The Phase 1 trial is a randomized, double-blind, placebo-controlled study assessing the safety and pharmacokinetics of ORKA-002 in 24 healthy adult participants. Subjects were administered this novel biologic through three ascending doses: 160 mg, 320 mg, and 640 mg.

Key Findings

  • Pharmacokinetics (PK): ORKA-002's half-life is over three times that of bimekizumab.
  • Pharmacodynamics (PD): The treatment effectively inhibited IL-17 signaling across all dose levels over a follow-up period of up to 24 weeks.
  • Safety: ORKA-002 demonstrated a favorable safety profile with minimal treatment-emergent adverse events (TEAEs), primarily headaches and skin abrasions.

Upcoming Phase 2 Trials for ORKA-002

Oruka anticipates launching the ORCA-SURGE trial in the first half of 2026. This study will evaluate approximately 160 patients with moderate-to-severe PsO. The primary endpoint will focus on achieving PASI 100 at Week 16.

In addition, a Phase 2 trial for ORKA-002 in HS is expected to begin in the second half of 2026.

Update on ORKA-001's EVERLAST-B Trial

The EVERLAST-B trial, which commenced dosing in December 2025, is exploring three induction dose levels of ORKA-001. Primary outcomes are also centered around the PASI 100 score at Week 16, with anticipated data release in 2027.

Dosing Strategy Overview

  • Induction doses: 37.5 mg, 300 mg, and 600 mg compared to a placebo.
  • Re-randomization at Week 28 based on PASI 100 achievement.

About Oruka Therapeutics

Oruka Therapeutics is committed to developing innovative biologics aimed at revolutionizing the treatment of chronic skin conditions. The company’s mission is to deliver high rates of complete disease clearance for patients suffering from conditions like plaque psoriasis, through infrequent dosing regimens.

For further information, visit www.orukatx.com or follow Oruka on LinkedIn.

Forward-Looking Statements

This announcement contains forward-looking statements regarding Oruka's business strategies and project timelines, including the anticipated results from ORKA-001 and ORKA-002. Actual outcomes may differ significantly due to various risks and uncertainties.

Related News