Johnson & Johnson (J&J) announced significant progress in its psoriasis treatment efforts on Monday, revealing successful results from two late-stage clinical trials of icotrokinra, an oral peptide designed to target inflammation associated with psoriasis and other immune-related diseases.
Developed in collaboration with Protagonist Therapeutics, icotrokinra is part of an ongoing effort to provide a more convenient alternative to injectable treatments currently used for inflammatory conditions. The drug aims to deliver similar, if not better, efficacy to injectables while offering the convenience of oral administration.
Icotrokinra works by targeting the IL-23 receptor, a pathway that plays a key role in psoriasis inflammation. This is the same pathway targeted by AbbVie’s Skyrizi and J&J’s own Tremfya, both of which are injectable medications.
According to David Risinger, an analyst at Leerink Partners, the results from the trials suggest that icotrokinra’s efficacy is “roughly comparable” to the injectable drug Stelara and may even outperform oral treatments such as Sotyktu and Otezla, which are also approved for psoriasis. However, Risinger cautioned that icotrokinra’s performance falls short of the effectiveness seen with Skyrizi and Tremfya, which could limit its ability to directly replace these established treatments.
The primary outcomes of J&J’s ICONIC-LEAD study included the Investigator’s Global Assessment (IGA) and the Psoriasis Area and Severity Index (PASI). By week 24, 74% of participants treated with icotrokinra showed significant improvement, scoring a 0 or 1 on the IGA scale, indicating clear or nearly clear skin. In terms of PASI, which assesses the severity of skin lesions, about half of icotrokinra users achieved a PASI 90 score—representing a 90% or greater improvement—by week 16, and 65% reached this threshold by week 24.
However, icotrokinra’s performance on PASI 90, adjusted for placebo response, was 45% by week 16, significantly lower than the 70% response seen in trials for Skyrizi and Tremfya.
Despite these differences, Risinger believes J&J’s forecast for icotrokinra, with potential peak annual sales exceeding $5 billion, remains intact. He suggests that the drug could help expand the market for IL-23 inhibitors.
Along with the ICONIC-LEAD study, J&J also announced positive results from a second Phase 3 trial, ICONIC-TOTAL, where icotrokinra met its primary endpoint on IGA by week 16, demonstrating a clear advantage over placebo.
Both studies will support J&J’s upcoming regulatory submissions. The company is also testing icotrokinra against Sotyktu, marketed by Bristol Myers Squibb, in two additional Phase 3 trials for moderate-to-severe plaque psoriasis. Additionally, trials for psoriatic arthritis are set to begin next year, with results from a Phase 2 trial in ulcerative colitis expected by June.
The success of icotrokinra in these Phase 3 trials has earned Protagonist Therapeutics a $165 million milestone payment from J&J, which the biotech company expects to receive in the first quarter of 2024.
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