Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORKA-002 · 2 trials · 2 indications
At least a 75% reduction from Baseline in the total abscess and inflammatory nodule count, with no increase from Baseline in abscess or draining tunnel count.
The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
| Arm | Type | Description |
|---|---|---|
| Induction Period - Arm 1 (ORKA-002) | EXPERIMENTAL | Participants will receive ORKA-002 per protocol Induction regimen. |
| Induction Period - Arm 2 (Placebo) | EXPERIMENTAL | Participants will receive Placebo per protocol Induction regimen. |
| (Induction Period - Arm 1) ORKA-002 | EXPERIMENTAL | Participants will receive ORKA-002 per protocol Induction regimen. |
| (Induction Period - Arm 2) ORKA-002 | EXPERIMENTAL | Participants will receive ORKA-002 per protocol Induction regimen. |
| (Induction Period - Arm 3) ORKA-002 | EXPERIMENTAL | Participants will receive ORKA-002 per protocol Induction regimen. |
| (Induction Period - Arm 4) Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo per protocol Induction regimen. |
| Name | Type | Description |
|---|---|---|
| ORKA-002 | DRUG | ORKA-002 administered by subcutaneous (SC) injection |
| Placebo | OTHER | Placebo administered by subcutaneous (SC) injection |
Inclusion Criteria: 1. Has signs and symptoms of HS for at least 6 months; 2. Has HS lesions present in ≥ 2 distinct anatomic areas, one of which must be at least Hurley Stage II or III; 3. Has a history of inadequate response to systemic antibiotic treatment for HS, exhibited recurrence of HS symp...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib, Lutikizumab |
| Incyte Corporation | INCY | 6 | PHASE3 | povorcitinib, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 15 | PHASE3 | Remibrutinib, Iscalimab, LYS006, Arumakimig, Ianalumab |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE2 | Duvakitug, Brivekimig, SAR445399 |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | Olatorepatide |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY072 |
| Oruka Therapeutics, Inc. | ORKA | 1 | PHASE2 | ORKA-002 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE1 | SAR447971 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE1 | Soquelitinib |
ORKA-002 is an investigational small molecule drug developed by Oruka Therapeutics, Inc. (ticker ORKA). It is being studied in hidradenitis suppurativa, plaque psoriasis, and healthy volunteers. ORKA-002 is designed to target IL-17A/F and is currently in clinical development, with Phase 1 and Phase 2 trials ongoing or completed.
ORKA-002 is being developed for the treatment of hidradenitis suppurativa (HS) and moderate-to-severe plaque psoriasis. It is also being evaluated in healthy volunteers in an early-stage study. The hidradenitis suppurativa and plaque psoriasis programs are in Phase 2, while the healthy volunteer study is a completed Phase 1 trial.
ORKA-002 targets IL-17A/F. By binding to the IL-17A and IL-17F cytokines, it is designed to inhibit inflammatory signaling associated with hidradenitis suppurativa and plaque psoriasis. The target class is an antibody, though ORKA-002 itself is a small molecule.
ORKA-002 is being developed by Oruka Therapeutics, Inc., which trades under the ticker ORKA. The company is the sponsor of the clinical trials evaluating ORKA-002 in hidradenitis suppurativa, plaque psoriasis, and healthy volunteers.
ORKA-002 is in Phase 1 and Phase 2 clinical development. A Phase 1 study in healthy volunteers has been completed, and two Phase 2 trials are currently recruiting: one in hidradenitis suppurativa and one in plaque psoriasis. It is investigational and has not been approved by the FDA.
ORKA-002 is being evaluated in three registered clinical trials. The Phase 1 healthy volunteer study is NCT06944379 and is completed. The Phase 2 hidradenitis suppurativa trial is NCT07783542, and the Phase 2 plaque psoriasis dose-ranging trial is NCT07474792. Both Phase 2 studies are currently recruiting participants.