After 12 weeks of treatment, three doses of Lilly’s mirikizumab beat placebo on the study’s primary endpoint, setting it up for late-stage testing.
Lilly’s immunology portfolio is relatively bare, with nearly all revenue coming from a single product: Taltz (Ixekizumab). That could change, however, if mirikizumab meets the company’s high hopes.
The drug has already advanced to late-stage testing for ulcerative colitis and plaque psoriasis, with readouts anticipated in 2020 and 2021, respectively. On a recent earnings call, chief scientific officer Dan Skovronsky said mirikizumab has potential to be first-in-class for ulcerative colitis.
Skovronsky noted too that, based on the positive results seen in Phase 2, Lilly intends to quickly move the drug into Phase 3 testing for Crohn’s.
Mirikizumab will need strong data to compete in the markets it’s heading toward. Takeda’s Entyvio (vedolizumab), for instance, holds approvals in both ulcerative colitis and Crohn’s. Across the company’s 2018 fiscal year, Entyvio fetched 269 billion Japanese yen ($2.4 billion), reflecting year-over-year growth of 34%.
Newer therapies like AbbVie’s upadacitinib and Celgene’s ozanimod may further crowd the Crohn’s drug market down the line as well. Yet the greatest challenge will arguably be in plaque psoriasis.
There, Johnson & Johnson and Novartis each have a blockbuster product in Stelara (ustekinumab) and Cosentyx (secukinumab). Taltz also holds an indication for plaque psoriasis, as is on pace to surpass $1 billion in revenue this year.
|Read on: Lilly drug scores in Phase 2 Crohn's study|