Johnson & Johnson’s latest prospective offering to the IL-23 psoriasis space—a Protagonist Therapeutics-partnered once-daily oral peptide—has passed a phase 3 checkpoint with results that could pad its case against Bristol Myers Squibb’s reigning oral psoriasis med Sotyktu.
The companies’ icotrokinra, or JNJ-2113, significantly cleared skin compared to placebo in patients with moderate to severe plaque psoriasis who were enrolled in the pivotal phase 3 study, dubbed ICONIC-LEAD.
At week 16, 64.7% of treated patients achieved clear or almost clear skin compared to placebo’s 8.3%, as measured by the Investigators Global Assessment scoring system. The finding hit one of the trial's co-primary endpoints. Meanwhile, 49.6% of patients saw a 90% or more improvement in a Psoriasis Area and Severity Index (PASI 90) score from baseline, meeting the other co-primary goal. Of those on placebo, 4.4% met the PASI 90 score.
Response rates continued to ramp up at week 24, when 74.1% of patients on icotrokinra had clear or almost clear skin and 64.9% achieved PASI 90.
J&J and Protagonist also said a smaller, separate phase 3 called ICONIC-TOTAL also met its main goal, with once-daily icotrokinra significantly clearing skin at week 16 compared to placebo. The study was conducted among patients with plaque psoriasis affecting special areas such as the scalp, genitals and/or hands and feet. Specific data from ICONIC-TOTAL was not shared.
The results make for an “industry-leading combination of significant skin clearance with demonstrated tolerability" in a once-daily pill, J&J said in a Nov. 18 press release.
With a competitive arena of IL-23 blockers and J&J's previous success in injectable contenders, the stakes were high for icotrokinra going into phase 3. While the oral peptide proved it could improve outcomes in phase 2 studies, the results didn’t quite live up to what J&J had seen during the phase 3 tests of its blockbuster injectable anti-IL-23 blocker Tremfya.
Still, the convenience of an oral delivery gave icotrokinra enough of an edge to move into the next trial phase and solidified its potential against BMS' Sotyktu, J.P Morgan said at the time.
Oral TYK2 inhibitor Sotyktu, for its past, achieved a PASI 90 score of 36% and 27% at week 16 in a pair of its own phase 3 trials.
Icotrokinra is currently going up against Sotyku in ongoing phase 3 studies and will also be evaluated in psoriasis arthritis early next year. The drug, which J&J touts as the first oral peptide designed to selectively block IL-23, was born out of a 2017 collaboration with Protagonist.