Johnson & Johnson (J&J) has reported initial findings from the Phase IIb FRONTIER 2 clinical trial, where JNJ-2113 offered high skin clearance rates over 52 weeks in subjects with moderate-to-severe plaque psoriasis.
JNJ-2113 is an interleukin-23 (IL-23) receptor-hindering investigational targeted oral peptide.
A long-term extension portion of the FRONTIER 1 study, FRONTIER 2 assessed the efficacy and safety of the oral peptide in treating moderate-to-severe plaque psoriasis.
The multicentre, double-blind, long-term extension, dose-ranging study, assessed the performance of JNJ-2113 across various dosages in 227 participants.
These subjects were randomised into six treatment groups and received treatment for 52 weeks.
According to the findings, high rates of skin clearance were observed through 52 weeks, with the 100mg twice-daily dosage group showing the highest Psoriasis Area and Severity Index (PASI) 75 response rates.
Secondary endpoints, including PASI 90, PASI 100, and Investigator's Global Assessment scores, were also maintained through Week 52.
The oral peptide’s safety in the FRONTIER 2 study was reported to be in line with FRONTIER 1.
In subjects who received JNJ-2113, 58.6%% of them had adverse events (AEs).
Nasopharyngitis, upper respiratory tract infection and Covid-19 were observed to be the most commonly reported AEs.
Last month, the company reported data from the Phase II FRONTIER 1 trial of JNJ-2113 for plaque psoriasis.
The Phase III ICONIC clinical development programme is currently evaluating JNJ-2113's safety and efficacy in larger populations.
This includes comparisons with placebo and deucravacitinib in the ICONIC-LEAD and ICONIC-TOTAL studies, under the collaboration between Protagonist Therapeutics and Janssen Biotech, a division of Johnson & Johnson.
The potential of JNJ-2113 extends beyond psoriasis, as evidenced by the initiation of the ANTHEM-UC Phase IIb study for ulcerative colitis.
Co-discovered by J&J in partnership with Protagonist Therapeutics, JNJ-2113 could be used to treat various other IL-23-mediated diseases.
J&J holds the sole rights for develop and market the oral peptide across the globe.
J&J immunodermatology disease area leader and vice-president Lloyd Miller said: “Our strong commitment to innovation in Immunodermatology advances our overall mission to bring new treatment options to market to achieve remission in patients with immune-mediated conditions.
“With promising longer-term results showcasing one year of JNJ-2113 data from the FRONTIER 2 study, our focused innovation in the IL-23 pathway provides an exciting opportunity to unlock a new and potentially differentiated treatment option for patients with psoriasis.”
