Protagonist announces NDA submission by Johnson & Johnson for icotrokinra

Protagonist Therapeutics (PTGX) announced the submission of a New Drug Application to the U.S. Food and Drug Administration by Johnson & Johnson (JNJ) seeking the first approval of icotrokinra, an investigational targeted oral peptide for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis. Icotrokinra is uniquely designed to block the IL-23 receptor,which underpins the inflammatory response in plaque PsO and offers potential in other IL-23-mediated diseases. Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. The NDA includes data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO. Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events between icotrokinra and placebo groups, with no new safety signals identified to date.