Johnson & Johnson (J&J) has announced positive outcomes for its investigational drug JNJ-2113 from the FRONTIER 2 trial, the long-term extension of Phase 2b FRONTIER 1 study.

JNJ-2113 is the first and only investigational targeted oral peptide designed to block the IL-23 receptor, which plays a key role in pathogenic T-cell activation in plaque psoriasis (PsO).

The drug boosts the inflammatory response in PsO and other dermatological, rheumatological and gastroenterological IL-23-mediated diseases.

It was discovered and being developed by Janssen Biotech, a pharmaceutical company of J&J, and Protagonist Therapeutics, under a license and collaboration agreement signed in 2017.

J&J retains exclusive worldwide rights to develop JNJ-2113 in Phase 2 clinical trials and to commercialise the compounds derived from the research in multiple indications.

JNJ-2113 is the first targeted oral peptide designed to block the IL-23 receptor, to treat moderate-to-severe plaque PsO and other IL-23-mediated diseases, said the US drugmaker.

Johnson & Johnson vice president and immunodermatology disease area leader 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.”

FRONTIER 2 is a Phase 2b multi-centre, double-blind, long-term extension, dose-ranging study designed to evaluate the efficacy and safety of JNJ-2113 to treat plaque psoriasis.

It is a long-term extension of the Phase 2b FRONTIER 1 study, which enrolled a total of 337 participants, of which 255 participants were randomized into six treatment groups.

A total of 227 participants from the FRONTIER 1 study entered the FRONTIER 2 long-term extension study and received at least one dose of study intervention, at Week 16.

In the FRONTIER 2 study, patients who initially received JNJ-2113 for the first 16 weeks in the FRONTIER 1 continued with the same dosing regimen.

The drug helped maintain high rates of skin clearance through 52 weeks, and its responses were maintained for all five JNJ-2113 treatment groups, through Week 52.

FRONTIER 2 has met the key secondary endpoints of PASI 90, PASI 100, Investigator’s Global Assessment (IGA)c 0/1 and IGA 0, with a safety profile that was consistent with FRONTIER 1.

The outcomes from the FRONTIER 1 and FRONTIER 2 clinical trials suggest the potential of JNJ-2113 across the spectrum of additional IL-23-mediated diseases.

Furthermore, J&J has initiated the Phase 2b ANTHEM-UC study in active ulcerative colitis, and the Phase 3 ICONIC programme in plaque PsO.

University of Pittsburgh dermatology professor Laura Ferris said: “Data from the FRONTIER 2 study showed that the skin clearance as seen by PASI 75 and higher-bar PASI 90 and 100 responses at 16 weeks was maintained at 52 weeks with no new safety signals across all JNJ-2113 treatment groups.

“These findings suggest the potential for JNJ-2113 to continue delivering clinically meaningful results, and addresses the high unmet need for a novel, durable, and convenient oral therapeutic option for people living with moderate-to-severe plaque psoriasis.”