Johnson & Johnson (J&J) and Protagonist Therapeutics’ investigational oral peptide icotrokinra (JNJ-2113) has been associated with significant skin clearance in patients with difficult-to-treat psoriasis, according to new data from a late-stage study of the candidate.
The phase 3 ICONIC-TOTAL trial has been evaluating the drug in adults and adolescents aged 12 years and older with at least moderate plaque psoriasis affecting high-impact skin sites.
It is estimated that eight million people in the US are living with plaque psoriasis, which causes inflamed, scaly plaques that may be itchy or painful.
Almost 25% of patients are affected by moderate-to-severe cases of the immune-mediated skin disease and, while the condition can occur anywhere on the body, psoriasis on highly visible areas or sensitive skin can have an increased negative impact on quality of life.
Results presented at this year’s Society for Investigative Dermatology annual meeting demonstrated that 57% of patients treated with once-daily icotrokinra achieved the study’s primary endpoint of an Investigator’s Global Assessment (IGA) score of zero or one (clear or almost clear skin) and at least a two-grade improvement from baseline at week 16, compared to 6% of patients randomised to receive placebo.
Among patients with scalp psoriasis, 66% achieved a scalp-specific IGA score of zero or one compared to 11% receiving placebo at week 16, while 77% of icotrokinra-treated genital psoriasis patients achieved a static Physician’s Global Assessment of Genitalia score of zero or one versus 21% of those in the placebo cohort at the same time point.
A higher rate of skin clearance was also seen in a smaller subset of patients with hand/foot psoriasis, with 42% of those in the icotrokinra group achieving a hand and/or foot Physician’s Global Assessment score of zero or one compared to 26% receiving placebo at week 16.
Study investigator, Melinda Gooderham, said: “Results from the ICONIC-TOTAL study demonstrate impressive rates of skin clearance in these difficult-to-treat areas and show the potential for treatment with icotrokinra to offer patients a novel therapeutic option that aligns with their treatment needs and preferences.”
Icotrokinra was jointly discovered and is being developed under a licence and collaboration agreement between J&J and Protagonist. Under the terms of the deal, J&J has exclusive global rights to develop the candidate in mid-stage studies and beyond, as well as to commercialise compounds derived from the research conducted in accordance with the agreement against multiple indications.