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. These can occur anywhere on the body and may be itchy or painful.
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.
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.
ICONIC-LEAD study investigator, Robert Bissonnette, Innovaderm Research, said: “These study results are promising, and show the potential for treatment with icotrokinra to offer patients the unique combination of complete skin clearance and a favourable safety profile in a once daily pill.”
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.