Protagonist Therapeutics announces icotrokinra application submitted to EMA

Protagonist Therapeutics (PTGX) announced the submission of an application to the European Medicines Agency by Johnson & Johnson (JNJ) seeking the first approval of icotrokinra, an investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe plaque psoriasis. Icotrokinra is an investigational targeted oral tablet that is designed to block the IL-23 receptor,which underpins the inflammatory response in PsO and offers potential in other IL-23-mediated diseases. The application included data from four Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEADa, ICONIC-TOTALb, and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2c. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and adolescents 12 years of age and older with moderate-to-severe PsO, demonstrating significant skin clearance and a favourable safety profile in a once-daily tablet, as previously established in the ICONIC-LEAD and ICONIC-TOTAL clinical studies. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe 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.