Icotrokinra Achieves Top Skin Clearance and Tolerability in Phase 3 Daily Pill Results

Johnson & Johnson has announced promising results from a key Phase 3 study evaluating icotrokinra (JNJ-2113), an innovative oral peptide targeting the IL-23 receptor, for treating moderate to severe plaque psoriasis in individuals aged 12 and above. The study, named ICONIC-LEAD, successfully met its co-primary endpoints, demonstrating significant improvement in skin clearance.

In this pivotal trial, a notable 64.7% of participants treated with icotrokinra achieved an Investigator's Global Assessment (IGA) score of 0/1, indicating clear or almost clear skin at the 16-week mark. Furthermore, 49.6% reached a 90% improvement in the Psoriasis Area and Severity Index (PASI 90). These outcomes were substantially higher compared to the placebo group, where only 8.3% and 4.4% of patients, respectively, achieved similar results. By week 24, the effectiveness of icotrokinra continued to rise, with 74.1% achieving IGA 0/1 and 64.9% reaching PASI 90.

Safety data from the trial indicated that the incidence of adverse events was comparable between the icotrokinra and placebo groups, at 49.3% and 49.1% respectively. These findings align with those observed in earlier Phase 2 studies, FRONTIER 1 and 2.

Additionally, the Phase 3 ICONIC-TOTAL study also reported positive topline results, with icotrokinra meeting its primary endpoint of achieving an IGA score of 0/1 at 16 weeks, compared to placebo. Detailed results from both ICONIC-LEAD and ICONIC-TOTAL are being prepared for presentation at future medical conferences and will be submitted to health authorities.

Liza O'Dowd, Vice President of Immunodermatology at Johnson & Johnson Innovative Medicine, expressed optimism about the potential of icotrokinra. She emphasized that the majority of individuals with moderate to severe plaque psoriasis remain under-treated despite being eligible for advanced therapies. Icotrokinra, as a once-daily oral treatment, could address this unmet need.

The ICONIC clinical development program continues with other Phase 3 studies, including ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which will compare the safety and efficacy of icotrokinra with both placebo and deucravacitinib. Additionally, the ICONIC-PsA program will commence in early 2025 to investigate icotrokinra for treating psoriatic arthritis.

Plaque psoriasis is a chronic immune-mediated condition characterized by an overproduction of skin cells, leading to inflamed, scaly plaques. It affects approximately eight million Americans and over 125 million people globally. Nearly a quarter of those affected have moderate to severe cases. The condition can significantly impact quality of life, especially when plaques appear in highly visible or sensitive areas such as the scalp, hands, feet, and genitals.

Icotrokinra, designed to selectively block the IL-23 receptor, represents a novel therapeutic approach in the management of plaque psoriasis. It binds with high affinity to the IL-23 receptor, effectively inhibiting IL-23 signaling, which plays a crucial role in the inflammatory process associated with psoriasis.

This investigational drug was developed through a collaboration between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company. Through their partnership, they aim to develop new treatments for inflammatory diseases, with Johnson & Johnson holding exclusive global rights to advance icotrokinra through clinical trials and commercialization.

With the promising results from the ICONIC-LEAD and ICONIC-TOTAL studies, icotrokinra offers hope for a new, effective treatment option for individuals suffering from moderate to severe plaque psoriasis. The ongoing clinical development efforts underscore Johnson & Johnson's commitment to advancing healthcare and improving patient outcomes.