Protagonist Therapeutics announced on Mar. 18 that the U.S. Food and Drug Administration has approved icotrokinra, an IL-23 receptor blocker developed in partnership with Johnson & Johnson, for the treatment of plaque psoriasis. The drug, which will be marketed as Icotyde, is the first oral IL-23 option available to patients and marks Protagonist's transition to a commercial-stage company.
The approval is significant because it introduces a new oral therapy in a market previously dominated by injectable treatments. Analysts from Truist Securities estimate that Icotyde could represent a $5 billion to $10 billion market opportunity. BMO Capital Markets analysts said, “As the first and only oral IL-23 option for patients, we see potential for Icotyde to differentiate, capture new patient segments and potentially take share from injectable options as it progresses through launch.”
Icotyde received what analysts described as a clean label from the FDA, with no requirement for mandatory tuberculosis testing—a distinction from other immunomodulatory agents that often include such requirements. BMO noted this could help improve initial uptake among physicians: “While this requirement has not been a large hindrance to physicians using biologic agents, we note this point as a differentiator for Icotyde which could improve initial uptake.”
With approval secured, Protagonist will receive a $50 million milestone payment from Johnson & Johnson under their licensing agreement signed in 2017. The company is also eligible for up to $580 million more in regulatory and sales milestones and will collect royalties ranging from 6% to 10% on global net sales. CEO Dinesh Patel said in a statement, “The FDA approval of Icotyde reflects a successful culmination of years of groundbreaking research and clinical development that began over 13 years ago in our laboratories and demonstrates the strength of our peptide technology platform to generate innovative therapies.”
Johnson & Johnson is conducting further studies of Icotyde in other diseases driven by IL-23, including psoriatic arthritis, ulcerative colitis, and Crohn’s disease. Additionally, head-to-head trials are ongoing against both Bristol Myers Squibb’s Sotyktu and J&J’s own Stelara.
Besides Icotyde, Protagonist is awaiting approval later this year for rusfertide—a blood cancer drug partnered with Takeda—and expects several data readouts that may expand its pipeline.
