J&J and Protagonist Therapeutics’ Oral Psoriasis Drug Shows Positive Results in Phase 3 Trial

Hailed as the first oral peptide designed to selectively block IL-23, Johnson & Johnson and Protagonist Therapeutics’ icotrokinra, or JNJ-2113, originated from a 2017 collaboration between the two companies. Although phase 2 results for the drug did not meet expectations, the companies’ decision to proceed with phase 3 trials has paid off, as the treatment successfully met its primary endpoints in a pivotal phase 3 study dubbed ICONIC-LEAD.
The trial enrolled patients suffering from moderate to severe plaque psoriasis and tested icotrokinra’s ability to clear skin compared to a placebo. Results revealed that the treatment was significantly more effective at clearing skin compared to the placebo, as measured by the Investigator’s Global Assessment (IGA) scoring system. At the 16-week mark, less than 9% of patients on placebo achieved clear or almost clear skin, whereas over 64.5% of patients who received the treatment achieved this milestone. These results confirmed that the trial successfully met one of its co-primary endpoints.

The second co-primary endpoint was also achieved. From the baseline Psoriasis Area and Severity Index (PASI 90) score, 49.6% of patients on icotrokinra showed a 90% improvement, compared to only 4.4% of patients on placebo.
This positive trajectory continued up to week 24, by which point over 74% of patients on icotrokinra had achieved clear or almost clear skin, and approximately 65% reached PASI 90.
A smaller, separate phase 3 study called ICONIC-TOTAL was also conducted for icotrokinra. This trial tested the efficacy of the drug in patients with plaque psoriasis, which affects special areas such as the scalp, genitals, and/or hands and feet, J&J and Protagonist shared. Although specific data from this trial has not been released, the companies announced that it too met its primary endpoint. At 16 weeks, compared to the placebo, the once-daily drug was able to significantly clear skin in patients.
In a press conference, J&J representatives said, “These results make for an industry-leading combination of significant skin clearance with demonstrated tolerability in a once-daily pill.”
Currently, the leading oral psoriasis medication on the market is Bristol Myers Squibb’s Sotyktu. In its phase 3 trials, the oral TYK2 inhibitor achieved a PASI 90 score of 36% and 27% at 16 weeks.

When it comes to J&J’s IL-23 blockers, its injectable drugs have historically performed better than its oral drug in phase 2 studies. The company’s blockbuster injectable anti-IL-23 blocker Tremfya set a high standard with its phase 3 results, which the oral medicine did not match. Nonetheless, J&J proceeded to phase 3 trials for icotrokinra, valuing the convenience of an oral delivery system.
According to JP Morgan, this strategic decision solidified icotrokinra’s potential as a competitor against BMS’s Sotyktu. Early next year, icotrokinra will be evaluated in psoriatic arthritis, but for now, it will continue to compete with Sotyktu in ongoing phase 3 studies.

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