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. The plaques may be itchy or painful and can occur anywhere on the body, including the scalp, elbows, knees and lower back.
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 J&J’s 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 0 (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: “The impacts of living with moderate-to-severe plaque psoriasis are felt across all aspects of life and many patients do not seek advanced treatments because they have concerns with injectables and prefer an oral therapeutic option.
“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.
Alongside the phase 3 development programme for JNJ-2113 in moderate-to-severe plaque psoriasis, initiated in the fourth quarter of 2023, J&J has launched a phase 2b clinical trial to evaluate the candidate in adults with ulcerative colitis, a chronic, immune-mediated condition that causes symptoms such as persistent diarrhoea and abdominal pain.