Protagonist Therapeutics announced positive topline results from its collaboration with Johnson & Johnson for icotrokinra (JNJ-2113) in two pivotal Phase 3 studies, ICONIC-LEAD and ICONIC-TOTAL, for moderate-to-severe plaque psoriasis. In the ICONIC-LEAD study, once-daily icotrokinra achieved its co-primary endpoints of PASI-90 and IGA of 0 or 1 at week 16, demonstrating significant skin clearance.
At week 16, 64.7% of patients treated with icotrokinra in ICONIC-LEAD achieved IGA scores of 0/1, and 49.6% achieved PASI 90, compared to 8.3% and 4.4% on placebo, respectively. Response rates further increased by week 24, with 74.1% achieving IGA scores of 0/1 and 64.9% achieving PASI 90, while safety data remained consistent with previous Phase 2 studies.
Following these positive results, Protagonist has earned $165 million in milestone payments under its amended collaboration agreement with Johnson & Johnson. This payment includes $115 million for successful Phase 3 completion, a $35 million accelerated payment for anticipated NDA acceptance in psoriasis, and a $15 million accelerated payment for initiating a Phase 3 study in a second indication. Protagonist remains eligible for up to $630 million in future development and sales milestones, plus tiered royalties of 6-10% on worldwide net sales.
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