Johnson & Johnson’s once-daily oral peptide has bested Bristol Myers Squibb’s reigning oral psoriasis med Sotyktu in a pair of phase 3 trials.
The Protagonist Therapeutics-partnered IL-23 inhibitor, called icotrokinra, hit the co-primary endpoints of the late-stage studies, which required at least a 2-grade improvement in plaque psoriasis at week 16 compared to placebo.
But it was the study’s secondary endpoints that gave a sense of icotrokinra’s potential to shake up the psoriasis space. Here, icotrokinra showed its superiority to Sotyktu at reducing the severity of psoriasis and size of lesions at weeks 16 and 24.
J&J made the announcement as part of its presentations at the American Academy of Dermatalogy's annual meeting, which runs March 7-11. While the Big Pharma didn’t drill down into the data for the Iconic-Advance 1&2 studies, the company did use the conference to reinforce the findings from a previous phase 3 plaque psoriasis win for icotrokinra in the Iconic-Lead study.
J&J reported back in November that Iconic-Lead had shown that 64.7% of icotrokinra-treated patients achieved clear or almost clear skin compared to placebo’s 8.3% at week 16. Meanwhile, 49.6% of patients saw a 90% or more improvement in their Psoriasis Area and Severity Index score compared to 4.4% of those on placebo.
Summarizing the results from all three trials, J&J said icotrokinra had proven that its “standout combination of complete skin clearance and favorable safety profile in a once daily pill could shift [the] treatment paradigm” for psoriasis.
“The robust results seen to date underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis,” Liza O'Dowd, vice president and immunodermatology disease area lead for Johnson & Johnson Innovative Medicine, said in the March 8 release.
“As part of our ongoing commitment to pioneer innovations for patients, we are proud to advance this first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, which shows promise as a potential first-line systemic therapy for the treatment of plaque psoriasis,” O’Dowd added.
Based on these clinical successes, J&J now wants to see how icotrokinra fares against its own med Stelara, which is approved for psoriasis among other inflammatory conditions. To this end, the company will launch the phase 3 Iconic-Ascend study, which the pharma is already describing as the “first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic in moderate-to-severe plaque psoriasis.”
Assessing the weekend's readouts, Leerink analysts said they view icotrokinra “primarily as an ‘IL-23 market expander.’”
“It is still somewhat unclear to what degree patients will prefer a once-daily oral pill with food restrictions (patients can’t consume anything other than water for 30 minutes after taking their daily pill) relative to quarterly Skyrizi maintenance dosing,” the analysts added in a March 10 note.
The clinical wins didn't end with psoriasis either. Monday morning, J&J also announced that icotrokinra had hit the primary endpoint of a phase 2 study in ulcerative colitis. All three doses of the drug demonstrated a clinical response at week 12, with a 63.5% response rate for the highest dose compared to 27% for the placebo cohort.
J&J touts icotrokinra, which was born out of a 2017 collaboration with Protagonist, as the first oral peptide designed to selectively block IL-23. The stakes have been high for the drug, bearing in mind the competitive arena of IL-23 blockers and J&J's previous success in injectable contenders. While icotrokinra 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 has meant that analysts had continued to argue that icotrokinra could be a serious competitor to BMS' Sotyktu.