By Sneha S K
April 27 (Reuters) – Oruka Therapeutics said on Monday that interim results showed its experimental drug helped clear psoriasis within 16 weeks, meeting the main goal of a mid-stage study and sending its shares up 27.1% in early trading.
The company was testing its monoclonal antibody ORKA-001 in patients with psoriasis, a chronic skin disease that causes itchy, scaly rashes, most commonly on the knees, elbows and scalp.
Oruka said the therapy led to complete skin clearance in 40 of 63 patients, or 63.5% patients, by week 16.
The data represents a best-in-class profile, demonstrating numerical superiority to AbbVie’s Skyrizi benchmark and comparable to UCB’s Bimzelx, which is often chosen for its rapid treatment response, said Barclays analysts.
ORKA-001 is designed to inhibit IL-23p19, an immune protein involved in psoriasis-related inflammation. The treatment is administered as an under-the-skin injection, designed to stay in the body longer, allowing dosing as infrequently as once or twice a year.
The results continue to support the potential for annual dosing, Oruka said.
“We think that most patients would prefer a once to twice per year biologic regimen with very high efficacy over a frequently administered oral,” said CEO Lawrence Klein on a call with analysts.
Currently approved treatments for this condition are typically given every 8 to 12 weeks.
Compared with other studies, Oruka said its drug showed higher rates of complete skin clearance than treatments targeting the same protein.
An earlier study showed ORKA-001 remained in the bloodstream longer and reached higher blood levels than Skyrizi at the same dose.
“If replicated in later-stage trials, ORKA-001 would be the best-in-indication biologic in psoriasis and exceed $10 billion of sales,” said TD Cowen analyst Tyler Van Buren.
If approved, ORKA-001 will enter a crowded psoriasis market, which the company estimates is currently worth over $30 billion, and compete with Bristol Myers Squibb’s Sotyktu, Johnson & Johnson’s Tremfya and oral pill Icotyde.
Oruka plans to share additional data on ORKA-001 later this year.
(Reporting by Sneha S K in Bengaluru; Editing by Shilpi Majumdar and Diti Pujara)
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