FRONTIER-2: Novel Oral Peptide Maintains Safety, Efficacy Out to 1 Year

JNJ-2113, which targets IL-23, also had an acceptable safety profile at 52 weeks.

A targeted oral peptide targeting interleukin-23 (IL-23) was associated with high rates of clearance and consistent safety through 1 year of treatment in adults with moderate-to-severe plaque psoriasis, according to new data presented at the American Academy of Dermatology 2024 Annual Meeting in San Diego.

FRONTIER-1 included 255 patients with moderate-to-severe plaque psoriasis who underwent randomization with JNJ-2113 or placebo for 16 weeks. At week 16, a total of 227 of those patients entered FRONTIER-2, which evaluated the results of FRONTIER-1   out to 52 weeks. Researchers measured efficacy using the Psoriasis Area and Severity Index (PASI). According to the new data in the extension study, high rates of skin clearance were maintained through 52 weeks in all treatment groups. Key secondary endpoints such as PASI 90 (64.3% at 52 weeks), PASI 100 (40.5% at 52 weeks), Investigator’s Global Assessment (IGA) 0/1 (73.8% at 52 weeks) and IGA 0 (42.9% at 52 weeks) were also maintained.

“We can see that the proportion of patients who achieved the primary efficacy endpoint in FRONTIER-1 was maintained out to 52 weeks,” Laura K. Ferris, MD, said in a presentation at the meeting.

Safety was also found to be consistent with the results from FRONTIER-1. While 58.6% of patients experienced adverse events, there was no evidence of dose-dependent increases in adverse events, including gastrointestinal disorders.

“With these promising longer-term results for JNJ-2113, we are excited by the possibility of unlocking a new and potentially differentiated oral treatment option that specifically and uniquely targets the well-established IL-23 pathway, which underpins the inflammatory response in psoriasis disease pathogenesis,” said Lloyd Miller, MD, PhD, vice president, Immunodermatology Disease Area Leader at Johnson & Johnson, in a statement to Practical Dermatology. “Our focus is on developing novel, effective therapies to ensure patients with immune-mediated conditions can one day achieve remission, and we are pleased that this data suggests we are moving in that direction.”

Source: Ferris L.  A Phase 2b, Long-term Extension, Dose-ranging Study of Oral JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis: FRONTIER-2. Session S026. Presented at: American Academy of Dermatology 2024 Annual Meeting; March 8-12, 2024; San Diego.

Disclosures: Dr. Ferris reports the following relationships: AbbVie – Consultant(Honoraria), Investigator(Other Financial Benefit); Acelyrin – Investigator(Grants/Research Funding); Amgen – Investigator(Other Financial Benefit); Arcutis, Inc. – Consultant(Honoraria), Investigator(Grants/Research Funding); Boehringer Ingelheim – Consultant(Honoraria), Investigator(Other Financial Benefit), Speaker(Honoraria); Bristol-Myers Squibb – Consultant(Honoraria), Investigator(Grants/Research Funding), Speaker(Honoraria); Cara Therapeutics – Consultant(Honoraria), Investigator(Grants/Research Funding); Castle Biosciences, Inc – Investigator(Other Financial Benefit); Dermavant Sciences – Consultant(Honoraria), Investigator(Grants/Research Funding); DermTech International – Consultant(Honoraria), Investigator(Other Financial Benefit); Eli Lilly and Company – Investigator(Other Financial Benefit); Galderma – Investigator(Grants/Research Funding); Janssen Pharmaceuticals, Inc – Consultant(Honoraria); Janssen Research & Development, LLC – Investigator(Other Financial Benefit); Leo Pharma Inc – Consultant(Honoraria); LEO Pharma, US – Investigator(Other Financial Benefit); Moberg Pharma North America LLC – Investigator(Grants/Research Funding); Novartis – Investigator(Other Financial Benefit); Pfizer Inc. – Data Safety Monitoring Board(Honoraria), Investigator(Grants/Research Funding); Regeneron – Consultant(Honoraria), Investigator(Other Financial Benefit); skinanalytics – Investigator(Grants/Research Funding); UCB – Investigator(Grants/Research Funding); Verrica Pharmaceuticals Inc – Investigator(Grants/Research Funding.