J&J's Oral IL-23 Inhibitor Icotrokinra Achieves Positive Phase 3 Results in Psoriasis
Key Insights
Johnson & Johnson's icotrokinra met primary endpoints in the ICONIC-LEAD phase 3 trial, demonstrating significant skin clearance in psoriasis (search) patients.
After 16 weeks, 64.7% of patients achieved clear or almost clear skin (IGA 0/1), and 49.6% showed a 90% or greater improvement in PASI score.
Icotrokinra's tolerability profile was consistent with previous phase 2 studies, with similar adverse event rates compared to placebo.
Johnson & Johnson's oral IL-23 (search) inhibitor, icotrokinra (formerly JNJ-2113), has achieved positive results in a phase 3 trial, marking a significant step toward a potential new treatment option for moderate to severe plaque psoriasis (search). The ICONIC-LEAD trial evaluated the efficacy and safety of once-daily icotrokinra in adults and adolescents (12 years and older) with the condition.
The topline results from the ICONIC-LEAD trial demonstrated that 64.7% of patients achieved an Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin) at week 16. Additionally, 49.6% of patients showed a 90% or greater improvement in the Psoriasis (search) Area and Severity Index (PASI) score at the same time point. After 24 weeks, these proportions increased to 74.1% and 64.9%, respectively.
The tolerability profile of icotrokinra was consistent with previous phase 2 studies (FRONTIER 1 and 2). At week 16, the incidence of treatment-emergent adverse events (TEAEs) was similar between the icotrokinra group (49.3%) and the placebo group (49.1%).
J&J (search) also reported positive topline results from the ICONIC-TOTAL phase 3 trial, where icotrokinra met the primary endpoint of an IGA score of 0/1 at week 16 compared to placebo.
Potential Impact on Psoriasis Treatment
Icotrokinra, if approved, could provide a more convenient oral alternative to injectable biologics, including IL-23 (search) inhibitors like J&J (search)'s Tremfya (guselkumab), AbbVie (search)'s Skyrizi (risankizumab), and Sun Pharma's Ilumya (tildrakizumab). J&J hopes that this new drug will extend its psoriasis (search) franchise, which currently includes Stelara (ustekinumab) and Tremfya.
"We are excited to see impressive phase 3 results with once-daily icotrokinra treatment aligned with our Phase 2 study of this first-in-class targeted oral peptide that selectively blocks the IL-23 (search) receptor," said Liza O'Dowd, J&J (search)'s immunodermatology disease area lead. She also noted that "The majority of people living with moderate-to-severe plaque psoriasis (search) are eligible for, but are still not receiving, advanced therapies," and that "Icotrokinra has the potential to offer once-daily oral therapy that could help address the needs and preferences of people living with plaque psoriasis."
Competition and Future Studies
J&J (search) is preparing for potential competition with Bristol-Myers Squibb (search)'s TYK2 inhibitor, Sotyktu (deucravacitinib), which has demonstrated strong sales growth due to its oral administration and efficacy comparable to injectable treatments. To directly compare icotrokinra with Sotyktu, J&J is conducting two additional phase 3 trials (ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2) comparing icotrokinra to placebo and Sotyktu, respectively.
Furthermore, J&J (search) is also exploring the potential of icotrokinra in other indications, with a phase 2 trial currently underway for ulcerative colitis (search).