Dive Brief:
- An experimental psoriasis drug from Oruka Therapeutics completely cleared the skin of nearly two thirds of those who received it in a mid-stage trial, suggesting the therapy may emerge as a threat to injectable, marketed medicines for the condition.
- According to Oruka, 40 of the 63 people treated with ORKA-001 in a Phase 2 trial achieved total skin clearance, or “PASI 100,” at 16 weeks, compared to only one of 21 placebo recipients. Additionally, 83% hit “PASI 90,” meaning they had clear or almost clear skin by that point. Side effects were consistent with what’s been observed in testing of other drugs that similarly block the inflammatory protein IL-23.
- While ORKA-001 wasn’t tested directly against other therapies, the PASI 100 rates were higher than what was observed in testing of AbbVie’s popular drug Skyrizi and comparable to UCB’s Bimzelx. Early data from another study also indicate the potential for once-yearly dosing, Oruka said. Company shares rose by about 20%.
Dive Insight:
Oruka was hatched by Paragon Therapeutics, a biotechnology company creator that has now launched a handful of spinouts developing antibody drugs, among them Apogee Therapeutics and Spyre Therapeutics. Oruka, Apogee and Spyre are all publicly traded and worth several billions of dollars.
Like Apogee and Spyre, Oruka has set its sights on immunological conditions. Oruka, though, is specifically zeroing in on skin disorders like plaque psoriasis and hidradenitis suppurativa, believing its prospects might emerge as superior versions of therapies already on the market.
The company’s top prospect, ORKA-001 is a monoclonal antibody targeting IL-23, a key player in the body’s inflammatory response and the target of several approved medicines. Oruka’s therapy, though, was designed to be an optimized version that can match the effectiveness of available therapies with less frequent dosing. Skyrizi, for example — which generated nearly $18 billion in sales last year — requires four injections per year.
The data disclosed Monday were the first indication in a placebo-controlled trial that ORKA-001 might separate itself from other medications. In a note to clients, Jefferies analyst Roger Song called the data an “outright win over Skyrizi” and supportive of a drug that could be worth $5 billion to $10 billion. Skyrizi posted PASI 100 rates of as much as around 51% in clinical testing, Song noted.
In a separate note, Stifel analyst Alex Thompson noted that the therapy’s efficacy also appeared “in-line” with Bimzelx, a different type of medicine that’s been off to a fast sales start. Oruka’s drug has the potential for “best-in-class efficacy, safety, and dosing within the psoriasis biologics market,” Thompson wrote.
Oruka reported no serious treatment-emergent adverse events among those who received ORKA-001 versus one such event among placebo recipients. The most common side effects reported were upper respiratory tract infections, which occurred in 19% of participants taking ORKA-001.
Oruka will share longer-term data the study in the second half of this year, and report results from a second Phase 2 trial in 2027.
