Janssen reports positive results from phase 2b FRONTIER 1 trial of JNJ-2113 in plaque psoriasis patients

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