Johnson & Johnson's Oral Psoriasis Drug Icotrokinra Demonstrates Superior Efficacy Over BMS’s Sotyktu in Phase 3 Trials

Mar 11, 2025 08:35 CST Updated 08:35

Johnson & Johnson

Medical Device R&D and Manufacturer

Protagonist Therapeutics

Developer of Novel Therapies

Johnson & Johnson's once-daily oral therapy icotrokinra, developed in collaboration with Protagonist Therapeutics, has shaken the market with impressive data from two Phase III trials—showing superior efficacy compared to Bristol-Myers Squibb's (BMS) blockbuster oral drug Sotyktu, while demonstrating best-in-class full skin clearance and safety.

ICONIC-ADVANCE 1 and 2: In the two global Phase III trials, icotrokinra achieved the co-primary endpoints: at 16 weeks, patients showed at least a 2-grade improvement in psoriasis plaques (compared to placebo).Key Secondary Endpoint PerformanceIcotrokinra outperformed BMS's Sotyktu (generic name: deucravacitinib) in reducing the severity of psoriasis and shrinking lesion areas, maintaining its advantage consistently in long-term evaluations at 16 weeks and 24 weeks.

Previously, the phase III trial data of ICONIC-LEAD published in November 2024 showed that: 64.7% of patients using icotrokinra achieved complete or near-complete skin clearance after 16 weeks (compared to only 8.3% in the placebo group); 49.6% of patients reached a Psoriasis Area and Severity Index (PASI 90) improvement of ≥90% (compared to only 4.4% in the placebo group).

Johnson & Johnson's Next Challenge: Directly Taking on Stelara, Testing if Oral Can Replace Injection

The company has announced the launch of the phase III trial ICONIC-ASCEND, which will compare the oral drug icotrokinra head-to-head with its leading injectable drug Stelara (ustekinumab, with annual sales exceeding $10 billion) for the first time. The trial aims to demonstrate the efficacy of the oral drug.Non-inferiority or even superiorityIf successful, it will shift the treatment of psoriasis towards home-based oral regimens. However, challenges remain. Although oral formulations are more acceptable to patients, whether their efficacy can match Stelara's high skin clearance rate (shown in multiple studies to exceed 80%) still needs verification.

As the first oral IL-23R targeted drug, which can bind to IL-23R with single-digit picomolar affinity and potently and selectively inhibit IL-23 signaling in human T cells. Currently, in addition to Johnson & Johnson, companies such as AbbVie and Novartis are also developing similar pipelines. However, icotrokinra, with the first-mover advantage of its Phase III data, is expected to capture the market first.

Reference: Company official website

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