J&J's ($JNJ) IL-23 blocker came through in a Phase IIb psoriasis study, with one of the top doses clearing symptoms of the disease in 86% of patients. Easily beating out the placebo response, the top psoriasis contender--which is facing off against a lineup of competing remedies in late-stage development--also beat out Humira in the study.
The best response came in the 100-mg dose group, with 86% of the patients getting the injectable drug seeing either complete clearance or only minimal evidence of psoriasis after 16 weeks of therapy. At 15 mg, the response rate was 61% with 83% of the 200-mg dose responding. In the 100-mg drug arm, 79% and 62% also registered PASI 75 and PASI 90 scores for the Psoriasis Area Severity Index.
"Moreover," J&J added in a statement, "complete clearance (PGA 0 and PASI 100) was observed in 62% and 54%, respectively, of patients in the guselkumab 100-mg dose group after 40 weeks of continuous treatment."
J&J recently completed their Phase III enrollment for guselkumab, putting them in head-to-head competition with a full slate of competitors. One of those rivals is brodalumab, a drug that had wrapped three successful late-stage studies and was cited as a likely blockbuster by AstraZeneca ($AZN). But just as Amgen ($AMGN) and AstraZeneca were prepping their regulatory filings, Amgen decided to drop out of the deal, citing evidence of suicidal thinking in the data that it believes will put the therapy at a competitive disadvantage if it hits the market.
Brodalumab had no trouble beating Stelara in studies, but that's not the competition that Amgen has in mind. Novartis is already well in front with its IL-17 program for secukinumab, approved in January as Cosentyx. Eli Lilly ($LLY) has also been racking up positive late-stage studies for its IL-17-blocking ixekizumab, trailed by Merck's ($MRK) MK-3222 and J&J's guselkumab.
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| Kristian Reich |
"The Phase IIb guselkumab study results show that blockade of IL-23 resulted in significant skin clearance, and improvements continued through week 40 with every 8- or 12-week maintenance treatment," said Professor Kristian Reich, the study investigator. "These findings provide important insights into the role of IL-23 in the pathogenesis of psoriasis and the potential therapeutic benefit of guselkumab. Findings from the Phase III guselkumab studies will provide greater insights into the efficacy and safety profile of this novel monoclonal antibody."
- here's the release