In the last minute, late-stage race to the market with a new round of psoriasis drugs, India’s Sun Pharmaceuticals is making its own bid with a new drug called tildrakizumab. In-licensed from Merck, which agreed to handle the late-stage work for Sun for the former MK-3222, it’s another IL-23 drug, like J&J’s guselkumab.
But it didn’t perform as well as the J&J drug in late-stage development.
Over the weekend, Sun touted a late breaker at EADV which demonstrated that their drug hit the primary endpoint in the study, adding improved 28-week scores that demonstrated it was effective in a majority of patients.
The trouble, though, is that their drug was clearly overshadowed by guselkumab, another IL-23 drug that’s now angling to hit the market to compete against two other recent arrivals: Novartis’s Cosentyx and Eli Lilly’s Taltz (ixekizumab). Both of those drugs are IL-17 therapies, a group which Valeant may well soon join after its application for brodalumab — in-licensed from AstraZeneca — goes through.
First, the data.
An average of 64% and 78% of patients receiving two injections of a 200 mg dose achieved PASI 75 score after 12 and 28 weeks. The data further showed that a higher number of patients on tildrakizumab achieved PASI 90 and 100 compared to placebo and Enbrel (etanercept). For tildrakizumab, 54% and 59% of patients (at 100 mg and 200 mg) achieved PASI 90 at week 28, significantly better than Enbrel’s 31%.
But therein lies the rub.
At week 16, the guselkumab patients achieved a 73.3% PASI 90 rate. At week 24, the proportion of patients who achieved a PASI 90 response was significantly higher in the guselkumab group compared with the Humira group (80.2% vs. 53%, respectively).
Guselkumab not only handily beat out Sun’s drug, the Sun therapy also scored uncomfortably close to the old mainstay Humira, which is — sometime in the next few years — going to go generic.
“I think it’s very hard to compare between studies,” says Jesper Jensen, Sun’s executive vice president for biologics and dermatology, who believes that tildrakizumab is well set up for its coming review by the FDA and likely arrival on the market.
Both drugs have helped demonstrate that IL-23 is a good target for psoriasis, he adds. In addition: “We’re still seeing many patients not getting to goal.”
The two drugs were also dosed differently, says Jensen, which could also explain the difference in the outcomes.
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