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Icotrokinra Shows Promise in Phase 3 Trials for Plaque Psoriasis

• Icotrokinra, an oral peptide targeting the IL-23 receptor, met primary endpoints in two Phase 3 trials for moderate-to-severe plaque psoriasis. • The ICONIC-LEAD trial demonstrated that 64.7% of patients achieved clear or almost clear skin at week 16, significantly higher than placebo. • In the ICONIC-TOTAL trial, icotrokinra also met the primary endpoint of achieving clear or almost clear skin at week 16 compared to placebo. • Icotrokinra, developed by Johnson & Johnson and Protagonist Therapeutics, could offer a convenient once-daily oral therapy option.

Johnson & Johnson (J&J) and Protagonist Therapeutics have announced positive top-line results from two Phase 3 trials evaluating icotrokinra (JNJ-2113), an investigational targeted oral peptide, in adult and adolescent patients with moderate-to-severe plaque psoriasis. The studies, ICONIC-LEAD and ICONIC-TOTAL, demonstrated significant improvements in skin clearance compared to placebo.
The ICONIC-LEAD trial evaluated icotrokinra in patients aged 12 years and older. At week 16, 64.7% of icotrokinra-treated patients achieved Investigator’s Global Assessment (IGA) scores of zero or one (clear/almost clear skin), and 49.6% achieved at least a 90% improvement on the Psoriasis Area and Severity Index (PASI 90), compared to 8.3% and 4.4% of patients receiving placebo, respectively. Response rates continued to increase at week 24, with 74.1% achieving IGA 0 or 1 and 64.9% achieving PASI 90.
The ICONIC-TOTAL trial also met its primary endpoint, demonstrating a statistically significant improvement in IGA scores of zero or one at week 16 compared to placebo.
Plaque psoriasis affects an estimated 125 million people worldwide and is characterized by inflamed, scaly plaques resulting from the overproduction of skin cells. These plaques can be itchy or painful and can occur anywhere on the body.

Mechanism of Action

Icotrokinra is designed to selectively block the IL-23 receptor, which plays a vital role in the pathogenic T-cell activation involved in psoriasis and other immune-mediated inflammatory diseases. By blocking this receptor, the drug aims to reduce the inflammatory response and alleviate the symptoms of the disease.

Potential Impact

"The majority of people living with moderate-to-severe plaque psoriasis are eligible for, but are still not receiving, advanced therapies," said Liza O’Dowd, vice president, immuno-dermatology disease area lead, J&J Innovative Medicine. "Icotrokinra has the potential to offer once-daily oral therapy that could help address the needs and preferences of people living with plaque psoriasis."
Icotrokinra was jointly discovered and is being developed pursuant to a license and collaboration agreement between Protagonist and J&J. J&J retains exclusive worldwide rights to develop the candidate in mid-stage clinical trials and beyond, and to commercialize compounds derived from the research conducted in accordance with the agreement against a broad range of indications.
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Reference News

[1]
J&J and Protagonist share promising phase 3 results for icotrokinra in plaque psoriasis
pmlive.com · Nov 25, 2024

J&J and Protagonist Therapeutics report positive phase 3 results for icotrokinra in treating moderate-to-severe plaque p...

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