J&J's Oral Psoriasis Drug Outperforms BMS' Sotyktu in Phase 3 Trials, Signaling Potential Shift in Treatment Paradigm

Johnson & Johnson (J&J) has announced promising results from two phase 3 trials for its oral psoriasis drug, icotrokinra, developed in partnership with Protagonist Therapeutics. The once-daily oral peptide has demonstrated superiority over Bristol Myers Squibb's (BMS) Sotyktu, potentially reshaping the landscape of psoriasis treatment.

Icotrokinra's Clinical Success

The Iconic-Advance 1 and 2 trials, presented at the American Academy of Dermatology's annual meeting, showed that icotrokinra met its co-primary endpoints. The drug achieved at least a 2-grade improvement in plaque psoriasis at week 16 compared to placebo. More notably, icotrokinra proved superior to Sotyktu in reducing psoriasis severity and lesion size at weeks 16 and 24.

These results build upon the earlier success of the Iconic-Lead study, where 64.7% of icotrokinra-treated patients achieved clear or almost clear skin compared to 8.3% on placebo at week 16. Additionally, 49.6% of patients saw a 90% or greater improvement in their Psoriasis Area and Severity Index score, compared to 4.4% in the placebo group.

Potential Impact on Psoriasis Treatment

Liza O'Dowd, vice president and immunodermatology disease area lead for Johnson & Johnson Innovative Medicine, emphasized the drug's potential: "The robust results seen to date underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis."

J&J is positioning icotrokinra as a possible first-line systemic therapy for plaque psoriasis. The company highlights its "standout combination of complete skin clearance and favorable safety profile in a once daily pill" as key factors that could revolutionize psoriasis treatment.

Future Studies and Market Implications

Building on these successes, J&J plans to launch the phase 3 Iconic-Ascend study, comparing icotrokinra directly against its own injectable biologic, Stelara. This head-to-head study aims to demonstrate the superiority of an oral medication over an established injectable treatment, potentially marking a significant shift in psoriasis management.

Icotrokinra, the first oral peptide designed to selectively block IL-23, emerged from a 2017 collaboration between J&J and Protagonist Therapeutics. While earlier phase 2 results were promising, they didn't match the efficacy of J&J's injectable anti-IL-23 blocker, Tremfya. However, the convenience of oral administration and the recent phase 3 results position icotrokinra as a serious competitor to BMS' Sotyktu and other psoriasis treatments.

As the pharmaceutical landscape continues to evolve, icotrokinra's performance in these trials signals a potential paradigm shift in psoriasis treatment, offering patients and healthcare providers a promising new option in managing this chronic condition.