Protagonist Therapeutics announces presentation of data on JNJ-2113

Protagonist Therapeutics announced a late-breaking presentation at the American Academy of Dermatology 2024 Annual Meeting with results from the Phase 2b FRONTIER 2 long-term extension study evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor, for adult patients with moderate-to-severe plaque psoriasis. JNJ-2113 is being developed by J&J Innovative Medicin, under a license and collaboration agreement with Protagonist, and is currently enrolling four pivotal Phase 3 psoriasis studies in the ICONIC clinical development program and one Phase 2b ulcerative colitis study. FRONTIER 2 enrolled patients who completed the 16-week dose ranging FRONTIER 1 Phase 2b study and evaluated patients from Week 17 through Week 52. In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque psoriasis, as measured by Psoriasis Area and Severity Index response rates of 75%, 90% and 100%. Recently, results from FRONTIER 1 were published in The New England Journal of Medicine and showed superior efficacy of JNJ-2113 at all doses tested and similar safety compared to placebo at Week 16. In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque psoriasis. In the five JNJ-2113 treatment groups, response rates were maintained from Week 16 to Week 52 with the highest PASI 75 response observed in the 100 mg twice daily group. Similar to the primary endpoint, responses were maintained through Week 52 for all five JNJ-2113 treatment groups for the key secondary endpoints of PASI 90, PASI 100, Investigator’s Global Assessment 0/1 and IGA 0. Safety in the FRONTIER 2 long-term extension study was found to be consistent with the observations made in the FRONTIER 1 study. Treatment was generally well tolerated, and the proportions of patients with adverse events were comparable between patient groups. There was no evidence of dose-dependent increase in AEs across the treatment groups. The four Phase 3 ICONIC studies in the clinical development program are currently underway to evaluate the safety and efficacy of JNJ-2113 in adults with moderate-to-severe plaque PsO, including the ICONIC-LEAD and ICONIC-TOTAL studies. The ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 will evaluate the safety and efficacy of JNJ-2113 compared with both placebo and deucravacitinib. In addition, J&J is enrolling the Phase 2b ANTHEM-UC study to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in participants with moderately-to-severely active ulcerative colitis.