Johnson & Johnson (J&J) and Protagonist Therapeutics reported promising results from two pivotal Phase III trials, ICONIC-LEAD and ICONIC-TOTAL, for their oral IL-23-targeting peptide, icotrokinra (JNJ-2113), in patients aged 12 and older with moderate to severe plaque psoriasis. The studies demonstrated significant skin clearance, meeting the primary endpoints in both trials.
Liza O’Dowd, Immunodermatology Disease Area Lead at J&J Innovative Medicine, highlighted the potential of icotrokinra to address unmet needs in psoriasis treatment. “Despite qualifying for advanced therapies, many patients with moderate to severe disease are not receiving them,” O’Dowd said. “Icotrokinra offers a once-daily oral treatment that could better meet the needs and preferences of those living with plaque psoriasis.”
Strong Skin Clearance Results
The ICONIC-LEAD trial enrolled 684 patients who were randomized to receive either once-daily icotrokinra or a placebo. The study’s co-primary endpoints were Psoriasis Area and Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) 0/1 with at least a 2-grade improvement. At week 16, 64.7% of icotrokinra-treated patients achieved clear or almost clear skin (IGA scores of 0/1), and 49.6% achieved a PASI 90 response, compared to just 8.3% and 4.4% of placebo recipients, respectively. Efficacy continued to improve at week 24, with 74.1% of icotrokinra patients achieving IGA scores of 0/1, and 64.9% achieving PASI 90.
In addition, the ICONIC-TOTAL study, which focused on psoriasis affecting special areas such as the scalp, genitals, and hands/feet, demonstrated the drug’s effectiveness in treating difficult-to-manage psoriasis. The study involved 311 patients and met its main goal of an IGA score of 0/1 with at least a 2-grade improvement at week 16.
Safety Data and Next Steps
Safety data from both trials were consistent with previous Phase II findings, with similar rates of adverse events between icotrokinra and placebo groups. Both companies plan to present detailed results at upcoming medical congresses and submit data for regulatory approval.
Milestone Payments and Future Prospects
As part of their 2020 collaboration, Protagonist will receive a $165 million milestone payment from J&J in the first quarter of 2025. This includes $115 million for the successful completion of the Phase III studies, $35 million for an NDA acceptance in psoriasis, and $15 million for the initiation of a Phase III study in another indication. Protagonist is also eligible for up to $630 million in future milestones and 6-10% royalties on global net sales.
Dinesh Patel, CEO of Protagonist, emphasized that the results validate the company’s peptide technology platform, which has led to the development of highly differentiated new chemical entities.
Expanding Clinical Trials
The collaborative ICONIC clinical program includes additional studies, such as ICONIC-ADVANCE 1 and 2, which will evaluate icotrokinra’s safety and efficacy in moderate to severe plaque psoriasis compared to a placebo and Bristol Myers Squibb’s Sotyktu (deucravacitinib). A Phase IIb ANTHEM study for ulcerative colitis is also nearing completion. The first top-line results for ICONIC-ADVANCE 1 and 2 and ANTHEM are expected in the first half of 2025.
J&J’s current immunology portfolio includes the IL-23 blocker Tremfya (guselkumab) and the dual IL-23/IL-12 inhibitor Stelara (ustekinumab), both approved for treating autoimmune conditions.
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