J&J, Protagonist's Oral Psoriasis Drug Outperforms BMS' Sotyktu in Phase 3 Trials

Johnson & Johnson (J&J) is making strides in the field of psoriasis treatment with its once-daily oral peptide, icotrokinra. This new medication has shown promising results in a series of clinical trials, surpassing the performance of Bristol Myers Squibb's Sotyktu, a current leading oral psoriasis medication. The encouraging outcomes from these studies position icotrokinra as a potential game-changer in the treatment of plaque psoriasis.

In two phase 3 trials, icotrokinra achieved the co-primary endpoints, which required at least a two-grade improvement in plaque psoriasis at week 16 when compared to a placebo. However, it was the secondary endpoints that highlighted icotrokinra’s potential for reducing psoriasis severity and lesion size at weeks 16 and 24, surpassing the results associated with Sotyktu.

During the American Academy of Dermatology's annual meeting, Johnson & Johnson shared these findings, confirming the successes of the Iconic-Advance 1 and 2 studies. Although specific data details were withheld, the presentation reinforced the positive results seen in the earlier Iconic-Lead study. In that study, 64.7% of patients receiving icotrokinra experienced clear or nearly clear skin by week 16, compared to just 8.3% in the placebo group. Additionally, nearly half of the patients witnessed a 90% or greater improvement in their Psoriasis Area and Severity Index score, a stark contrast to the 4.4% seen in the placebo cohort.

Summarizing these outcomes, J&J highlighted icotrokinra’s potential to change the treatment landscape for moderate-to-severe plaque psoriasis. The company emphasized the drug’s ability to deliver complete skin clearance combined with a favorable safety profile, all in a daily pill form. Liza O'Dowd, Vice President and Immunodermatology Disease Area Lead at J&J Innovative Medicine, expressed the company’s dedication to innovation, underscoring icotrokinra’s role as a selective IL-23 receptor blocker and its promise as a possible first-line systemic therapy.

Looking forward, Johnson & Johnson aims to evaluate icotrokinra against its own product, Stelara, another treatment for psoriasis and other inflammatory conditions. The upcoming phase 3 Iconic-Ascend study will offer a head-to-head comparison between icotrokinra and the injectable biologic Stelara, marking a first in such trials.

Analysts from Leerink noted the potential of icotrokinra to expand the IL-23 inhibitor market. However, they pointed out some uncertainties regarding patient preferences, especially concerning the oral pill’s food restrictions, which necessitate fasting except for water 30 minutes post-ingestion, relative to Skyrizi's quarterly maintenance dosing.

The positive results for icotrokinra extend beyond psoriasis. Johnson & Johnson also announced success in a phase 2 trial for ulcerative colitis, where icotrokinra met its primary endpoint. All three dosages of the drug showed a clinical response by week 12, with the highest dose achieving a 63.5% response rate, compared to 27% for the placebo group.

Icotrokinra is the product of a collaboration with Protagonist Therapeutics initiated in 2017 and stands out as the first oral peptide specifically designed to block IL-23. Given the fierce competition among IL-23 inhibitors and J&J's past achievements with injectable treatments, icotrokinra's progress is noteworthy. Although phase 2 outcomes did not entirely match the phase 3 results of J&J's injectable Tremfya, the convenience of an oral form suggests icotrokinra could still pose significant competition to Bristol Myers Squibb's Sotyktu.