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JNJ-2113 Demonstrates Significant Skin Clearance in Phase 3 Psoriasis Trials

• Phase 3 trials ICONIC-LEAD and ICONIC-TOTAL showed JNJ-2113 significantly improved skin clearance in moderate-to-severe plaque psoriasis patients compared to placebo. • In ICONIC-LEAD, 64.7% of patients on JNJ-2113 achieved IGA 0/1 at week 16, versus 8.3% on placebo, with PASI 90 achieved by 49.6% versus 4.4%, respectively. • Week 24 results from ICONIC-LEAD showed further improvement, with 74.1% achieving IGA 0/1 and 64.9% achieving PASI 90 with JNJ-2113. • ICONIC-TOTAL also met its primary endpoint of IGA 0/1 at week 16, reinforcing JNJ-2113's potential as a novel oral treatment for plaque psoriasis.

Protagonist Therapeutics, in collaboration with Johnson & Johnson, has announced positive phase 3 data for JNJ-2113 (icotrokinra), a once-daily oral peptide, in patients aged 12 years and older with moderate-to-severe plaque psoriasis. The ICONIC-LEAD and ICONIC-TOTAL trials demonstrated significant skin clearance compared to placebo, marking a potential advancement in psoriasis treatment.

ICONIC Trial Results

The ICONIC-LEAD trial (NCT06095115) enrolled 684 individuals with plaque psoriasis, with or without psoriatic arthritis, who had a total body surface area involvement of ≥10%, a Psoriasis Area and Severity Index (PASI) score of ≥12, and an Investigator Global Assessment (IGA) score of ≥3. The results showed that at week 16, 64.7% of patients treated with JNJ-2113 achieved IGA scores of 0/1 (clear or almost clear skin), compared to only 8.3% in the placebo group. Furthermore, 49.6% of patients on JNJ-2113 achieved PASI 90 (at least a 90% reduction in PASI score) versus 4.4% on placebo.
Responses continued to improve at week 24, with 74.1% of patients on JNJ-2113 achieving IGA scores of 0/1 and 64.9% achieving PASI 90.
The ICONIC-TOTAL trial (NCT06095102), which included 311 patients, also met its primary endpoint, demonstrating a significantly higher proportion of patients achieving an IGA score of 0/1 at week 16 with JNJ-2113 compared to placebo.

Mechanism of Action and Potential Impact

JNJ-2113 (formerly PN-235) is a potential first-in-class targeted oral peptide designed to selectively block the IL-23 receptor. By blocking the IL-23 receptor, JNJ-2113 aims to interrupt the inflammatory cascade that leads to the development of psoriatic plaques.

Expert Commentary

"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 [JNJ-2113] 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 Therapeutics. He added, "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."
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Reference News

[1]
New phase 3 data of JNJ-2113 for plaque psoriasis in patients aged 12 years, older
contemporarypediatrics.com · Nov 20, 2024

Positive phase 3 data for JNJ-2113 (icotrokinra) showed significant skin clearance in moderate-to-severe plaque psoriasi...

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