Spring house:The Janssen Pharmaceutical Companies of Johnson & Johnson has announced positive topline results from its Phase 2b FRONTIER 1 clinical trial evaluating the novel, first and only oral interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in adult patients with moderate-to-severe plaque psoriasis (PsO).
The trial achieved all primary and secondary efficacy endpoints. A greater proportion of patients who received JNJ2113 achieved PASI 75 (primary endpoint) as well as PASI 90 and PASI 100 (75, 90 and 100 percent improvement in skin lesions as measured by the Psoriasis Area and Severity Index, respectively) compared to placebo, at week 16. Trial results for JNJ-2113 demonstrated a profile that supports its advancement into Phase 3 clinical development for moderate-to-severe plaque PsO in adult patients.
JNJ-2113 is a novel oral IL-23R antagonist peptide that binds with high affinity to the IL-23R and has properties that allow it to be absorbed with oral dosing. The IL-23/IL-23R signaling pathway plays a critical role in the pathogenesis of immunemediated inflammatory diseases, including PsO. JNJ-2113 selectively and potently blocks IL-23 signaling and downstream inflammatory cytokine production.
PASI 75 Results – Primary Endpoint
The proportions of adult patients receiving JNJ-2113 (n=212) who achieved PASI 75 demonstrated the following dose responses at week 16 compared to 9.3 percent of patients receiving placebo (n=43) (nominal p ≤0.002 for all comparisons):
• 37.2 percent at 25 mg daily (n=43)
• 51.2 percent at 25 mg twice daily (n=41)
• 58.1 percent at 50 mg daily (n=43)
• 65.1 percent at 100 mg daily (n=43)
• 78.6 percent at 100 mg twice daily (n=42)
PASI 90 Results – Secondary Endpoint
The proportions of adult patients receiving JNJ-2113 who achieved PASI 90 demonstrated the following dose responses at week 16 compared to 2.3 percent of patients receiving placebo (n=43) (nominal p ≤0.002 for all comparisons):
• 25.6 percent at 25 mg daily (n=43)
• 26.8 percent at 25 mg twice daily (n=41)
• 51.2 percent at 50 mg daily (n=43)
• 46.5 percent at 100 mg daily (n=43)
• 59.5 percent at 100 mg twice daily (n=42)
PASI 100 Results – Secondary Endpoint
The proportions of adult patients receiving JNJ-2113 who achieved PASI 100 also demonstrated the following dose responses at week 16 compared to 0 percent of patients receiving placebo (n=43) (nominal p ≤0.05 for all comparisons):
• 11.6 percent at 25 mg daily (n=43)
• 9.8 percent at 25 mg twice daily (n=41)
• 25.6 percent at 50 mg daily (n=43)
• 23.3 percent at 100 mg daily (n=43)
• 40.5 percent at 100 mg twice daily (n=42)
Treatment was generally well tolerated, and the proportions of patients with adverse events were comparable between patient groups. The proportion of participants experiencing one or more adverse events (AEs) was 52.4 percent (n=111) in the combined JNJ-2113 group and 51.2 percent (n=22) in the placebo group. Although there was variability across the treatment groups, there was no evidence of a dose-dependent increase in the occurrence of specific AEs across the JNJ-2113 treatment groups. The most frequent system organ class involved in AEs in all groups was infections and infestations, which were 30.2 percent (n=64) vs. 27.9 percent (n=12) in the combined JNJ-2113 group vs. placebo group, respectively; of these, the most common were comparable between groups: COVID-19 (10.8 percent [n=23] vs. 11.6 percent [n=5]), nasopharyngitis (7.1 percent [n=15] vs. 4.7 percent [n=2]) and upper respiratory tract infection (2.4 percent [n=5] vs. 2.3 percent [n=1]).
“Patients are looking for more flexible and convenient treatment options to manage the signs and symptoms of psoriasis, and these positive early results for JNJ-2113 are encouraging,” said Robert Bissonnette, M.D., FRCPC, Chief Executive Officer and Medical Director, Innovaderm, Montreal, Canada, and Lead Investigator of the FRONTIER clinical trial. “The majority of people living with moderate-to-severe plaque psoriasis are eligible for but are still not receiving advanced therapies. For many patients, a pill is preferable to an injection.”
“The development of a novel oral therapy that specifically targets IL-23R could potentially change the treatment paradigm for patients living with moderate-tosevere plaque psoriasis,” said Lloyd Miller, M.D., Ph.D., Vice President, Immunodermatology Disease Area Stronghold Leader, Janssen Research & Development, LLC. “Until now, advanced psoriasis treatments have been largely limited to injectable biologics. An oral therapy that can uniquely inhibit the IL-23 pathway by directly targeting the IL-23 receptor could help address the needs and preferences of patients, and may offer greater freedom, with the aim of driving greater adoption of advanced treatment.” These findings from the FRONTIER 1 clinical trial suggest the potential of JNJ-2113 across the spectrum of additional IL-23-mediated diseases; and as a next step, Janssen plans to advance JNJ-2113 into Phase 3 development for moderate-tosevere plaque PsO and initiate a Phase 2b clinical trial for adults living with ulcerative colitis.
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