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Protagonist Announces Positive Topline Results From Phase 3 ICONIC Studies of Icotrokinra (JNJ-2113), a First-in-Class Investigational Targeted Oral Peptide That Selectively Blocks the IL-23 Receptor in Plaque Psoriasis
NEWARK, CA / ACCESSWIRE / November 18, 2024 / Protagonist announces positive topline results from Phase 3 ICONIC studies of icotrokinra (JNJ-2113), a
About this update from Protagonist Therapeutics, Inc.
[{"type":"text","content":"NEWARK, CA / ACCESSWIRE / November 18, 2024 / Protagonist announces positive topline results from Phase 3 ICONIC studies of icotrokinra (JNJ-2113), a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor in plaque psoriasisICONIC-LEAD achieved its co-primary endpoints of PASI-90 and IGA of 0 or 1 at week 16; 74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24ICONIC-TOTAL achieved its primary endpoint of IGA score of 0 or 1 at week 16 in patients with plaque psoriasis in difficult-to-treat areasProtagonist has earned a $165 million milestone under the terms of recently amended agreement, inclusive of $50 million in accelerated paymentsNEWARK, Calif. - November 18, 2024 - Protagonist Therapeutics, Inc. (\"Protagonist\" or the \"Company\") today announced positive topline results from its collaboration with Johnson & Johnson, in ICONIC-LEAD[1] and ICONIC-TOTAL[2], two pivotal Phase 3 investigational studies of icotrokinra (JNJ-2113, formerly PN-235), the first-in-class targeted oral peptide that selectively blocks the IL-23 receptor, in individuals 12 years of age and older with moderate to severe plaque psoriasis (PsO).In the ICONIC-LEAD study, once-daily icotrokinra showed significant skin clearance versus placebo in adults and adolescents with moderate to severe plaque psoriasis. At week 16, nearly two-thirds (64.7%) of patients treated with icotrokinra achieved IGA[3] scores of 0/1 (clear or almost clear skin), and 49.6% achieved PASI 90[4], compared to 8.3% and 4.4% on placebo, respectively. Further increases in response rates continued to be observed at week 24, with 74.1% of patients treated with icotrokinra achieving IGA scores of 0/1, and 64.9% achieving PASI 90. Safety data was found to be consistent with the Phase 2 FRONTIER 1 and 2 studies. A similar proportion of patients experienced adverse events (AEs) between icotrokinra and placebo, with 49.3% and 49.1% of participants experiencing a treatment emergent adverse event (TEAE) at week 16. In addition, positive topline results from the Phase 3 ICONIC-TOTAL study showed once-daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo.\"These positive Phase 3 results confirm the compelling efficacy and safety trends that were observed with the previous Phase 2b FRONTIER-1 and -2 stu...