J&J presents successful data from plaque psoriasis trial  

Clinical trial

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor. 

IL-23 plays a critical role in pathogenic T-cell activation in moderate-to-severe plaque psoriasis (PsO) and underpins the inflammatory response in PsO and other dermatological, rheumatological and gastroenterological IL-23-mediated diseases.  

FRONTIER 2 trial

In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque PsO. In the five JNJ-2113 treatment groups, as measured by the Psoriasis Area and Severity Index (PASI), response rates were maintained from Week 16 to Week 52, with the highest PASI 75 response observed in the 100mg twice daily group (78.6 at 16 weeks and 76.2% at 52 weeks). 

Similar to the primary endpoint, responses were maintained through Week 52 for all five JNJ-2113 treatment groups for the key secondary endpoints of PASI 90 (59.5 at 16 weeks and 64.3% at 52 weeks), PASI 100 (40.5% at 16 weeks and 40.5% at 52 weeks), Investigator’s Global Assessment (IGA)c 0/1 (64.3% at 16 weeks and 73.8% at 52 weeks) and IGA 0 (45.2% at 16 weeks and 42.9% at 52 weeks). 

Safety in the FRONTIER 2 long-term extension study (Week 16 through Week 52) was found to be consistent with FRONTIER 1. Across JNJ-2113 treatment groups, 58.6% of patients experienced adverse events (AEs), with no evidence of dose-dependent increase in AEs, including gastrointestinal disorders.  

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, and all serious AEs were considered unrelated to study treatment.

“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,” said Dr Laura Ferris, Professor of Dermatology, University of Pittsburgh. “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.”  

In FRONTIER 2, patients who originally received JNJ-2113 in FRONTIER 1 during the first 16 weeks continued with the same dosing regimen they received in the earlier part of the trial. Patients who were originally in the placebo group received JNJ-2113 100mg once daily in FRONTIER 2. Data from the Phase IIb FRONTIER 1 study evaluating JNJ-2113 in adults with moderate-to-severe PsO were recently published in The New England Journal of Medicine.

Phase III ICONIC trial

The pivotal Phase III ICONIC clinical development programme is currently underway to evaluate the safety and efficacy of JNJ-2113 in adults with moderate-to-severe plaque PsO, including the ICONIC-LEADe and ICONIC-TOTALf studies – pursuant to the license and collaboration agreement between Protagonist Therapeutics and Janssen Biotech. Other Phase III studies in the development programme have been initiated, including ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which will evaluate the safety and efficacy of JNJ-2113 compared with both placebo and deucravacitinib.  

The findings from the FRONTIER 1 and FRONTIER 2 clinical trials suggest the potential of JNJ-2113 across the spectrum of additional IL-23-mediated diseases. Accordingly, J&J has initiated the Phase IIb ANTHEM-UC study to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in participants with moderately to severely active ulcerative colitis.  

“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,” said Lloyd Miller, Vice President, Immunodermatology Disease Area Leader, Johnson & Johnson. “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.” 

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