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.
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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.
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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.
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By GlobalDataSecondary 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.”
