NEW BRUNSWICK (dpa-AFX) - Drug major Johnson & Johnson (JNJ) on Tursday announced positive Icotrokinra results, which showed that 75% of adolescents with plaque psoriasis or PsO achieved completely clear skin and demonstrated favorable safety profile in a once daily pill.
The company revealed the new icotrokinra (JNJ-2113) data from a subgroup analysis of ICONIC-LEAD, the first ever Phase 3 registrational study in moderate-to-severe PsO to assess efficacy and safety of a systemic therapy in adolescents and adults simultaneously.
PsO is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor and is being studied in adults and adolescents 12 years of age and older with moderate-to-severe plaque PsO.
Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johson company.
The data, presented at the 2025 World Congress of Pediatric Dermatology or WCPD Annual Meeting, show adolescents treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified.
In the trial, 84.1% of adolescent patients treated with once daily icotrokinra achieved an Investigator's Global Assessment or IGA score of 0/1 (clear or almost clear skin) and 70.5% achieved a Psoriasis Area and Severity Index or PASI 90 response, compared to 27.3% and 13.6% receiving placebo, respectively, at Week 16.
Response rates continued to improve through Week 24, the company added.
Liza O'Dowd, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine, said, 'Adolescents living with moderate to severe plaque psoriasis shouldn't have to wait for effective treatments options that have the potential to deliver completely clear skin, which is the driving force for studying this younger population as part of the pivotal ICONIC program. These data underscore the promise of next-generation therapies and the potential for icotrokinra to offer adolescents with moderate-to-severe plaque psoriasis the unique combination of a favorable safety profile and complete skin clearance in a once-daily pill.'
Johnson & Johnson said it retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.
Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis and active psoriatic arthritis and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis.
In the pre-market activity on the NYSE, JNJ shares were gaining around 0.6 percent to trade at $151.84.
On the Nasdaq, Protagonist shares were losing around 2.2 percent to trade at $41.63.
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