November 18, 2024，Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced positive topline results from its collaboration with Johnson & Johnson, in ICONIC-LEAD and ICONIC-TOTAL, 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). Learn more about our IL-23 catalog
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 scores of 0/1 (clear or almost clear skin), and 49.6% achieved PASI 90, 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 studies, highlighting icotrokinra's potential as a best-in-class oral agent providing an ideal combination of significant skin clearance with demonstrated tolerability in a once-daily pill for treating plaque psoriasis," said Dinesh V. Patel, PhD, President and CEO of Protagonist. "These results also continue to validate Protagonist's innovative peptide technology platform and its effectiveness in creating highly differentiated new chemical entities to address unmet needs in various disease areas."
Comprehensive results from both ICONIC-LEAD and ICONIC-TOTAL are being prepared for presentation at upcoming medical congresses and will be shared with health authorities in planned submissions.
Under the terms of the recently amended icotrokinra license and collaboration agreement with Johnson & Johnson, Protagonist has earned $165 million in milestone payments. These are inclusive of $115 million for successful completion of a Phase 3 study, a $35 million accelerated payment previously due upon acceptance of an NDA in psoriasis, and a $15 million accelerated payment previously due upon initiation of a Phase 3 study in a second indication. The $165 million payment, which the Company expects to receive in Q1 2025, has been earned under the agreement and is not refundable. The Company remains eligible for up to $630 million in future development and sales milestone payments, and tiered royalties of 6-10% on worldwide net sales.
Additional upcoming icotrokinra clinical studies and data anticipated in the first half of 2025 include:
Topline results for the Phase 2b ANTHEM multicenter, randomized, placebo- controlled, dose-ranging study of icotrokinra for the treatment of moderately to severely active ulcerative colitis[6].
Topline results for the Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 superiority studies, evaluating the safety and efficacy of icotrokinra compared with both placebo and deucravacitinib in moderate to severe plaque psoriasis.
An ICONIC-PsA psoriatic arthritis program evaluating icotrokinra in a phase 3 study in psoriatic arthritis (PsA) will be initiated in the beginning of 2025.
