Data from the FRONTIER 1 clinical trial were recently published in the New England Journal of Medicine.
Protagonist Therapeutics, Inc. recently announced1 the publication of data and findings from the phase 2b FRONTIER 1 trial (NCT05223868) investigating JNJ-2113 in adults with moderate-to-severe plaque psoriasis (PsO) in the New England Journal of Medicine.
JNJ-2113, the first- and only-in-class targeted oral peptide inhibitor of the IL-23 receptor, is currently undergoing clinical development.
The phase 2b trial, designed as a randomized, multicenter, double-blind, placebo-controlled study, aimed to evaluate the efficacy and safety of various doses of JNJ-2113 in patients with PsO.
In total, 255 adult patients with PsO were included in the trial, having been randomized into 1 of 6 treatment groups, including a placebo and 5 varying dose arms. These included 25 mg daily, 25 mg twice daily, 50 mg daily, 100 mg daily, and 100 mg twice daily. Patients were involved in a 4-week screening period, a 16-week treatment period, and a 4-week follow-up period to evaluate for safety.
In patients administered the highest dosage of 100 mg twice daily, 79% achieved a PASI-75 response, signifying a reduction of at least 75% in the Psoriasis Area and Severity Index score.
Furthermore, the same patient group exhibited significant improvements in Investigator's Global Assessment (IGA) scores, with 64.3% achieving an IGA score of 0/1, indicating minimal skin lesions.
The trial also delved into key Patient-Reported Outcomes (PROs), revealing substantial enhancements in patient-reported symptoms and quality of life. Patients treated with JNJ-2113 demonstrated greater improvements from baseline in the severity of their symptoms by week 16, as assessed by the Psoriasis Symptoms and Signs Diary.
Additionally, among patients with baseline Dermatology Life Quality Index (DLQI) scores greater than 1, significantly higher proportions of JNJ-2113-treated patients achieved DLQI scores of 0/1 (indicating no impact on quality of life) at week 16.
"Plaque psoriasis affects an estimated eight million Americans and more than 125 million people worldwide. Nearly one-quarter of the cases are considered moderate-to-severe and significantly impact daily life," said Scott Plevy, MD, executive vice president and therapeutic head of gastroenterology at Protagonist, in a news release.1 "The significant improvement in clinical and patient-reported outcomes reported in the NEJM article with a favorable safety profile is very encouraging, and we look forward to future data readouts from both the Phase 3 psoriasis ICONIC program and the ANTHEM-UC Phase 2b ulcerative colitis study."
As a result of these positive data, JNJ-2113 is currently being researched in several phase 3 trials for psoriasis as part of Protagonist's ICONIC program.
In October, Protagonist announced that JNJ-2113 would be advancing in clinical development programs for PsO and ulcerative colitis.2
Read more from Dermatology Times here.
Janssen first announced positive topline results stemming from research of JNJ-2113 in July 2023.3