In the trial, most patients who received JNJ-2113 achieved the primary endpoint of Psoriasis Area and Severity Index (PASI) 75 along with PASI 90 and PASI 100 compared to the placebo at week 16
Janssen reports positive topline results for JNJ-2113 from Phase 2b FRONTIER 1 trial. (Credit: Kjerstin Michaela Noomi Sakura Gihle Martinsen Haraldsen from Pixabay)
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that its interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 met all the primary and secondary efficacy endpoints in Phase 2b FRONTIER 1 clinical trial.
The trial evaluated JNJ-2113 in adult patients with moderate-to-severe plaque psoriasis (PsO).
JNJ-2113 is a novel oral antagonist peptide that binds with high affinity to the IL-23R. It also has properties that enable it to be absorbed with oral dosing. It blocks IL-23 signalling and downstream inflammatory cytokine production.
In the trial, most patients who received JNJ-2113 achieved the primary endpoint of Psoriasis Area and Severity Index (PASI) 75. The index measured the improvement in skin lesions.
The patients also achieved PASI 90 and PASI 100 compared to the placebo, at week 16.
Janssen Research & Development Immunodermatology Disease Area Stronghold Leader VP Lloyd Miller said: “The development of a novel oral therapy that specifically targets IL-23R could potentially change the treatment paradigm for patients living with moderate-to-severe plaque psoriasis.
“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.”
The FRONTIER 1 Phase 2b trial is a randomised, multicentre, double-blind, placebo-controlled clinical trial that assessed three once-daily dosages and two twice-daily dosages of JNJ-2113 taken orally.
It randomised 255 participants into six treatment groups for up to 24 weeks.
The primary endpoint was defined as the proportion of patients achieving PASI 75 at 16 weeks. The secondary endpoints include a change from baseline in PASI total score at week 16, the percentage of participants achieving PASI 90 and PASI 100 scores at week 16, and several other parameters.
According to Janssen, the results support the advancement of JNJ-2113 into a Phase 3 clinical trial for moderate-to-severe plaque PsO in adult patients. It also shows its potential throughout the spectrum of additional IL-23-mediated diseases.
The firm also plans to start a Phase 2b clinical trial that will assess IL-23R antagonist peptide in adults living with ulcerative colitis.