Johnson & Johnson (J&J) and Protagonist Therapeutics have announced positive top-line results from a late-stage study of their investigational targeted oral peptide in plaque psoriasis.

The phase 3 ICONIC-LEAD trial has been evaluating the candidate, icotrokinra (JNJ-2113), in adult and adolescent patients aged 12 years and older with moderate-to-severe cases of the immune-mediated disease.

Both co-primary endpoints were met, with 64.7% of icotrokinra-treated patients achieving Investigator’s Global Assessment (IGA) scores of zero or one (clear/almost clear skin) and 49.6% achieving at least a 90% improvement on the Psoriasis Area and Severity Index (PASI 90) at week 16, compared to 8.3% and 4.4% of patients receiving placebo, respectively.

Increases in response rates continued to be demonstrated at week 24, with 74.1% of patients randomised to receive icotrokinra achieving IGA scores of zero or one, and 64.9% achieving PASI 90.

The companies also shared promising top-line results from the phase 3 ICONIC-TOTAL trial, in which icotrokinra met the primary endpoint of IGA scores of zero or one at week 16 compared to placebo.

More than 125 million people worldwide are estimated to be living with plaque psoriasis, which results in the overproduction of skin cells and is characterised by inflamed, scaly plaques. These may be itchy or painful and can occur anywhere on the body, including the scalp, elbows, knees and lower back.

Icotrokinra is designed to selectively block the IL-23 receptor, which plays a vital role in the pathogenic T-cell activation of the condition and other immune-mediated inflammatory diseases.

Icotrokinra was jointly discovered and is being developed pursuant to a licence 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.