J&J gets Phase II win for first targeted oral peptide in plaque psoriasis

,
Johnson & Johnson

J&J gets Phase II win for first targeted oral peptide in plaque psoriasis

Published: Mar 11, 2024

By Tristan Manalac

BioSpace

Johnson & Johnson on Saturday unveiled long-term data from its Phase IIb FRONTIER 2 trial, demonstrating that its investigational peptide therapeutic JNJ-2113 could maintain high rates of skin clearance through one year in patients with moderate-to-severe plaque psoriasis.

J&J presented these data over the weekend at a late-breaking oral session at the American Academy of Dermatology’s Annual Meeting.

At 52 weeks, 76.2% of patients treated at the highest dosing schedule—100-mg, twice-daily—maintained their PASI-75 response, which indicates a 75% improvement in scores in the Psoriasis Area and Severity Index (PASI) tool. At 16 weeks, this regimen induced a 78.6% PASI-75 response.

JNJ-2113 was also able to maintain “higher-bar” responses through week 52, Laura Ferris, professor of dermatology at the University of Pittsburgh, said in a statement. PASI-100 which indicates a 100% improvement, stayed constant at 40.5% from 16 weeks to 52 weeks across all five JNJ-2113 treatment groups.

PASI-90, meanwhile, improved from 59.5% at 16 weeks to 64.3% at 52 weeks. Similarly, more patients scored 0 or 1 on the Investigator’s Global Assessment—indicating largely clear skin—at 52 weeks versus 16 weeks.

“These findings suggest the potential for JNJ-2113 to continue delivering clinically meaningful results,” Ferris said, adding that the candidate could also help satisfy the “high unmet need” in the psoriasis space for a novel, durable and convenient treatment option. Ferris disclosed that she is a paid consultant for J&J but has not been compensated for any media work.

In terms of safety, FRONTIER 2’s long-term data demonstrated that JNJ-2113 was largely well-tolerated. While 58.6% of treated patients developed adverse events, serious side effects were uncommon and arose only in 4% of patients across all dose groups of the study. All serious adverse events were also deemed unrelated to the candidate.

Saturday’s readout comes after the company released data from the Phase IIb FRONTIER 1 study in July 2023, demonstrating strong PASI-75 performance at 16 weeks. At the time, however, investors were largely disappointed in the findings, which were not on par with other injectable psoriasis treatments.

Jointly discovered and developed with Protagonist Therapeutics, JNJ-2113 is an investigational targeted oral peptide therapeutic that works by blocking the IL-23 receptor, easing the body’s inflammatory response and potentially targeting the underlying pathological mechanism of moderate-to-severe plaque psoriasis.

The companies first partnered in 2017 and in July 2021 amended their agreement to allow for the parallel development of different oral IL-23 receptor agonists. J&J is in charge of all future studies of JNJ-2113, which is now currently being evaluated in the pivotal Phase III ICONIC program.

As part of this late-stage program, J&J is running the ICONIC-ADVANCE 2 study which has an estimated enrollment target of 675 patients with moderate-to-sever plaque psoriasis, and which will pit JNJ-2113 against Bristol Myers Squibb’s Sotyktu (deucravacitinib).

Source: BioSpace