Johnson & Johnson (J&J) and Protagonist Therapeutics have announced new data from a late-stage programme of their investigational targeted oral peptide in plaque psoriasis.

Results from the phase 3 ICONIC-LEAD study presented at this year’s American Academy of Dermatology (AAD) annual meeting showed that the candidate, icotrokinra (JNJ-2113), was associated with significant skin clearance in adults and adolescents aged 12 years and older with moderate-to-severe cases of the immune-mediated skin disease.

More than 125 million people worldwide are estimated to be living with plaque psoriasis, which causes inflamed, scaly plaques.

In ICONIC-LEAD, 65% of patients receiving once-daily icotrokinra achieved an Investigator’s Global Assessment (IGA) score of zero or one (clear or almost clear skin) and 50% achieved at least a 90% improvement on the Psoriasis Area and Severity Index (PASI 90), compared to 8% and 4% of those randomised to receive placebo, respectively, at week 16.

Continued skin clearance improvement was also reported at week 24, with 74% of icotrokinra-treated patients achieving an IGA score of zero or one and 65% reaching PASI 90. Additionally, 46% of patients receiving icotrokinra achieved IGA zero and 40% reached PASI 100 at week 24.

The companies also shared promising results from the phase 3 ICONIC-ADVANCE 1 and 2 studies, which are evaluating icotrokinra against both placebo and deucravacitinib in adults with moderate-to-severe plaque plaque psoriasis, and announced the initiation “the first-ever head-to-head study in plaque psoriasis seeking to demonstrate the superiority of an oral pill… compared to an injectable biologic”.

Icotrokinra was jointly discovered and is being developed under a licence and collaboration agreement between Protagonist and J&J. J&J has 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.