Oruka Therapeutics’ long-acting plaque psoriasis candidate cleared the skin of 63.5% of patients in a phase 2a trial, leading Jefferies analysts to predict the asset could beat out AbbVie’s Skyrizi and generate sales of up to $10 billion. The biotech’s share price opened up 30% at $89.50.
The trial randomized 84 people with moderate-to-severe plaque psoriasis to receive two injections of ORKA-001 or placebo one month apart. At week 16, 40 of 63 participants treated with ORKA-001 had complete skin clearance on the PASI scale, compared to 1 of 21 patients on placebo, achieving the trial’s primary endpoint. ORKA-001 also beat placebo on other measures of psoriasis symptoms.
Importantly, cross-trial comparisons suggest ORKA-001 may be more effective than Skyrizi. ORKA-001 and Skyrizi both target interleukin-23 (IL-23), a cytokine that drives inflammation in plaque psoriasis and other conditions. Oruka has extended the half-life of ORKA-001 to enable less frequent dosing.
“This is unprecedented efficacy for an IL-23 inhibitor, and combined with the potential for annual dosing, another feature never achieved before in this indication, we think this could be a category-winning profile,” Oruka CEO Lawrence Klein, Ph.D., said on a call with analysts to discuss the data.
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The phase 2a readout “came out clean with [an] outright win over Skyrizi,” Jefferies analysts said in a note to investors. Skyrizi achieved complete skin clearance in up to 51% of patients in the studies cited (PDF) in the product’s FDA label. A 10% improvement in the skin clearance rate could change clinical practice, according to doctors quoted by the analysts. Skyrizi sales hit $17.6 billion last year across several indications.
Jefferies analysts said the ORKA-001 profile that emerged from the phase 2a trial could support sales of $5 billion to $10 billion. As well as achieving competitive efficacy, ORKA-001 delivered a clean safety profile in the phase 2a trial, with no serious treatment-emergent adverse events. Updated phase 1 data suggest once-yearly dosing is possible. Skyrizi is given every 12 weeks as a maintenance therapy.
Now, Oruka is turning its attention to phase 3. Klein said the company will probably use an active comparator in the trial, adding that “with data like these, it’s hard to avoid the thought of could you go head-to-head against some of the best products out there.” Historically though, new drugs haven’t needed to beat the best to win approval or market share, Klein said, and Oruka will take a “prudent path” with the design.
