J&J reveal long-term data for novel oral peptide

The first and only investigational targeted oral peptide has been shown to maintain high rates of skin clearance in adults with moderate-to-severe plaque psoriasis through 52 weeks, new data shows. In the long-term extension FRONTIER 2 study, JNJ-2113 demonstrated sustained efficacy from Week 16 to Week 52, based on data presented at the American Academy of Dermatology (AAD) 2024 Annual Meeting.

Johnson & Johnson stated that JNJ-2113 is the first targeted oral peptide designed to block the IL-23 receptor. IL-23 has a key role in pathogenic T-cell activation in moderate-to-severe plaque psoriasis, the company added.

Novel oral therapy shows potential in plaque psoriasis

Data summary

“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,” stated Dr Laura Ferris, PhD, Professor of Dermatology, University of Pittsburgh. The highest Psoriasis Area and Severity Index (PASI) PASI 75 response was seen in the 100mg twice daily group (78.6 at 16 weeks and 76.2 percent at 52 weeks), J&J reported.

“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,” explained Dr Ferris.

According to J&J, in FRONTIER 2, patients who originally received JNJ-2113 in the Phase II FRONTIER 1 study during the first 16 weeks continued with the same dosing regime from the earlier in the clinical trial. Individuals originally given placebo treatment, were administered JNJ-2113 100mg once daily in FRONTIER 2.

Potential of JNJ-2113

Significance of these new results

“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,” commented Dr Lloyd Miller, PhD, Vice President, Immunodermatology Disease Area Leader, Johnson & Johnson.

As a result, the company is evaluating JNJ-2113 in severely active ulcerative colitis in the Phase IIb ANTHEM-UC study.

While safety results were consistent with previously reported data (FRONTIER 1), across JNJ-2113 treatment groups, 58.6 percent of patients experienced adverse events (AEs), with no evidence of dose-dependent increase in AEs, including gastrointestinal disorders, J&J noted.