J&J’s Icotrokinra (JNJ-2113) Achieves Significant Success in Phase 3 Trials for Moderate to Severe Plaque Psoriasis

Positive Phase 3 Results:
Icotrokinra (JNJ-2113), a novel oral IL-23 receptor antagonist peptide, has shown positive topline results in Phase 3 clinical trials for moderate to severe plaque psoriasis[2][5].

Efficacy:
The drug met its co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) of 0/1 response at week 16, with continued improvement through week 24. At week 24, 74.1% of patients treated with icotrokinra achieved IGA scores of 0/1, and 64.9% achieved PASI 90[2][5].

Safety:
The safety data was consistent with the Phase 2 FRONTIER 1 and 2 studies, showing a similar proportion of patients experiencing adverse events between icotrokinra and placebo[2][5].

Development Partnership:
Icotrokinra was jointly discovered and is being developed pursuant to a license and collaboration agreement between Protagonist Therapeutics and Janssen Biotech, Inc., with Janssen retaining exclusive worldwide rights to develop and commercialize the drug[2][5].

Future Plans:
Comprehensive results from the Phase 3 studies are being prepared for presentation at upcoming medical congresses and will be shared with health authorities in planned submissions[2][5].

Additional Indications:
The success of icotrokinra in plaque psoriasis suggests potential for its use in other IL-23-mediated diseases, with a Phase 2b study initiated for ulcerative colitis[3].