Johnson & Johnson recently announced the first data from their FRONTIER 2 clinical trial which evaluated JNJ-2113. This is the first and only investigational targeted oral peptide designed to block the IL-23 receptor which plays a critical role in pathogenic T-cell activation in moderate-to-severe plaque psoriasis (PsO).
Results from Johnson & Johnson’s FRONTIER 2 clinical trial showed that JNJ-2113 demonstrated sustained efficacy from Week 16 to Week 52 for patients with moderate-to-severe PsO.
In the five JNJ-2113 treatment groups, response rates, which were measured using the Psoriasis Area and Severity Index (PASI), were maintained from Week 16 to 52. The highest PASI 75 response was observed in the group that received 100 mg twice a day, with 78.6% achieving the endpoint at Week 16 and 76.2% at Week 52.
Responses were also maintained for the secondary endpoints of PASI 90 (59.5% at Week 16 and 64.3% at Week 52), and PASI 100 (40.5% at Week 16 and 40.5% at Week 52).
A total of 58.6% of patients in the FRONTIER 2 study experienced adverse events (AEs), however, there was no evidence of any dose-dependent increase in AEs. The most frequently reported AEs were nasopharyngitis (18.1%), upper respiratory tract infection (9.7%) and COVID-19 (5.3%). Serious AEs were uncommon, occurring in 4% of the combined JNJ-2113 patients through Week 52. All serious AEs were considered unrelated to treatment.
According to Laura Ferris, MD, PhD, professor of dermatology at the University of Pittsburgh, who presented these findings at the 2024 American Academy of Dermatology Meeting, “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.”
