Dive Brief:
- An experimental pill developed by Johnson & Johnson and Protagonist Therapeutics significantly cleared skin in most people with moderate-to-severe plaque psoriasis who enrolled in a Phase 3 trial run by J&J.
- Treatment with the drug, called icotrokinra, led to clear or almost clear skin in about two-thirds of participants after four months of testing. Just under half experienced a 90% or greater reduction in their scores on another measure of psoriasis plaque coverage and severity. Only 8% and 4%, respectively, of study participants on placebo hit those same marks.
- Responses to icotrokinra improved further through six months and, according to a Monday statement from J&J, a similar percentage of participants in both trial groups experienced side effects. The company plans to present detailed results at an upcoming medical meeting.
Dive Insight:
Icotrokinra is the product of a research collaboration J&J and Protagonist struck just over seven years ago. It’s meant to match, or at least come close to, the effectiveness of injectable drugs now commonly used to treat inflammatory conditions like psoriasis, but with the convenience of being taken orally.
Drugmakers the industry over have embarked on a similar mission, investing in medicines aimed at an array of enzymes and proteins that help control the body’s immune response.
Icotrokinra takes aim at receptor known as IL-23, blocking the same signaling pathway as AbbVie’s fast-selling injection Skyrizi and J&J’s own Tremfya.
The good news from Monday’s results, according to Leerink Partners’ David Risinger, is that icotrokinra’s efficacy seems “roughly comparable” to the older injectable drug Stelara and potentially “superior” to oral drugs like Sotyktu and Otezla that are approved for psoriasis.
However, the analyst wrote in a client note Tuesday, icotrokinra seems less effective than Skyrizi and Tremfya, which may limit its ability to directly replace those treatments.
The main measures of success in J&J’s study, called ICONIC-LEAD, were improvements on the Investigator’s Global Assessment, or IGA, and the Psoriasis Area and Severity Index, or PASI. Scores of 0 or 1 on IGA correspond to clear or nearly clear skin and, by week 24, 74% of icotrokinra-treated participants met that criteria.
PASI, by comparison, measures the total area of skin affected by psoriasis plaques, as well as how red and thick those plaques are. So-called PASI 90 refers to a 90% or greater improvement in PASI scores compared to baseline measurements. About half of the people on icotrokinra hit this threshold by week 16, and 65% did by week 24.
Adjusted for placebo response rates through week 16, icotrokinra’s 45% rate on PASI 90 is well below the roughly 70% rate seen in trials of Skyrizi and Tremfya, according to Risinger.
Still, Risinger expects J&J can eventually meet its forecast of greater than $5 billion in peak annual sales of icotrokinra, as he sees it helping expand the market share of IL-23 drugs.
In addition to announcing data from ICONIC-LEAD, J&J also said that another Phase 3 study, ICONIC-TOTAL, succeeded, showing once-daily icotrokinra met its main goal on IGA compared to placebo by week 16.
Results from both studies will be included in approval applications J&J is now preparing.
The company is also testing its drug against Sotyktu, which is sold by Bristol Myers Squibb, in two Phase 3 trials of people with moderate-to-severe plaque psoriasis. Studies evaluating icotrokina in psoriatic arthritis are set to begin next year, while results from a Phase 2 test in ulcerative colitis are anticipated before June.
As a result of icotrokinra’s success in Phase 3, Protagonist has earned $165 million in milestone payments from J&J, which the biotechnology company said it expects to receive from J&J in the first quarter.
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- Source: https://www.biopharmadive.com/news/johnson-johnson-protagonist-icotrokinra-il-23-psoriasis/733306/