Eli Lilly and Incyte are investing heavily in JAK inhibitor Olumiant’s chances in atopic dermatitis with a suite of phase 3 studies—and it just put up a pivotal win in another of them. But does the latecomer really stand a chance against Sanofi and Regeneron’s steamroller Dupixent?
Olumiant beat out standard-of-care topical corticosteroids in reducing the symptoms of atopic dermatitis (AD) after 16 weeks in patients whose symptoms had not been controlled by cyclosporine, according to top-line phase 3 data released Monday.
Patients treated with a 2-milligram dose of Olumiant in the Breeze-AD4 study achieved 75% clearer skin over baseline at a significantly higher rate than patients treated with placebo who failed to respond to cyclosporine.
Breeze-AD4 studied the efficacy and safety of 1-, 2- and 4-milligram doses of Olumiant over placebo, with only the 2-milligram dose showing statistically significant results, Lilly said. The drug’s safety profile was consistent with previous studies and no deaths or venous thromboembolic events were reported.
Olumiant is facing regulatory review in Europe as a treatment for AD, and the drugmakers expect to file in the U.S. and Japan this year. The partners plan to present full findings from the Breeze-AD4 study at an upcoming medical meeting, they said in a release.
Lilly and Incyte will find themselves fighting an uphill battle, though, if Olumiant wins that new nod. Sanofi and Regeneron’s Dupixent is way in the lead in that market, and analysts are mostly split on the potential newcomer’s chances.
In note to investors Monday, Cantor analyst Louise Chen called the newest Olumiant data “good news” for Lilly, “which is important given how competitive the market is becoming.”
Other analysts, alas, have not viewed Olumiant’s forecast quite so fondly.
After Lilly and Incyte released top-line data from another phase 3 Olumiant study in AD––dubbed Breeze-AD7––in August, SVB Leerink analyst Geoffrey Porges painted Dupixent, also known as dupilumab, as a clear favorite in the indication with its higher response rates. He also noted a pulmonary embolism reported in the Olumiant arm of that trial.
“We believe that we now know enough about the current generation of JAK inhibitors to more or less dismiss them as threats to Dupi in benign dermatological and atopic indications,” he wrote in a note to investors at the time.
Olumiant, which in 2018 won approval to treat rheumatoid arthritis (RA) with its 2-milligram dose after an initial rejection, has faced blowback from the FDA for its higher dose, and those safety concerns have derailed its sales push.
Regulators slapped a Black Box warning on Olumiant’s 2-milligram dose for risk of infections, malignancy and thrombosis. For the higher dose, the FDA knocked Lilly and Incyte for unclear safety and efficacy data after an advisory committee voted to turn it down.
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Meanwhile, Dupixent has taken the AD market by storm with $1.56 billion in sales in the first nine months of 2019. In December, Sanofi CEO Paul Hudson made the bold prediction that Dupixent could be on it way to capturing a $21 billion U.S. market in AD––potentially putting the drug’s peak sales between $10 billion and $11 billion.
That prediction could be tempered somewhat, analysts argued, by the sheer number of competitors aiming for a stake in that megablockbuster field, including not just Olumiant but also Dermira’s lebrikizumab, Pfizer’s abrocitinib and 22 other drugs at some stage of the pipeline, Cantor analysts said in December.
Dermira made news back in March when it released data from a phase 2b trial showing lebrikizumab performed better on the widely used Eczema Area and Severity Index (EASI) test than Dupixent did in the pivotal trials that led to its approval. Even though lebrikizumab is way behind in this race—top-line results from its phase 3 program aren’t expected till early 2021—Dermira’s stock soared 95% on the better-than-expected phase 2 data.
The FDA followed that promising data up in December, handing lebrikizumab its fast track designation.
