Johnson & Johnson (J&J) and Protagonist Therapeutics’ investigational targeted oral peptide that selectively blocks the IL-23 receptor has shown promise as a treatment for moderate-to-severe plaque psoriasis, according to newly-published phase 2b results in the New England Journal of Medicine.
More than 125 million people worldwide are estimated to be living with plaque psoriasis, an immune-mediated disease resulting in the overproduction of skin cells, which causes inflamed, scaly plaques.
IL-23 plays a vital role in the pathogenic T-cell activation of the condition and other immune-mediated inflammatory diseases.
Results from the phase 2b FRONTIER 1 trial showed that a greater proportion of patients who received the candidate, JNJ-2113, achieved the trial’s primary endpoint of a Psoriasis Area and Severity Index (PASI) score of 75 compared to placebo at week 16, with 79% of patients receiving JNJ-2113 100mg twice-daily achieving PASI 75.
The data was also consistent with the trial's secondary endpoints, J&J said, with 40.5% of patients who received the highest dose of JNJ-2113 achieving PASI 100 and 45.2% achieving IGA zero (clear skin).
Improvements were also observed across patient-reported outcomes, and rates of adverse events were generally similar between the JNJ-2113 and placebo groups.
Lloyd Miller, vice president, immunodermatology disease area leader at J&J, said: “We are encouraged by the study findings published in the New England Journal of Medicine, including consistency across clinician- and patient-reported outcomes and objective biomarkers. If approved, JNJ-2113 has the potential to improve both clinical and quality of life outcomes.”
JNJ-2113 was jointly discovered and is being developed pursuant to a license and collaboration agreement between Protagonist and J&J. J&J retains exclusive worldwide rights to develop the candidate in mid-stage clinical trials and beyond, and to commercialise compounds derived from the research conducted in accordance with the agreement against a broad range of indications.
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