Gilead Sciences, Inc. GILD, which was once considered one of the front-runners in the race to develop a drug for non-alcoholic steatohepatitis, or NASH, has been facing setback after setback.
What Happened
A little more than two months after it reported failed results for a late-stage study dubbed STELLAR-4, Gilead said Thursday that another Phase 3 study dubbed STELLAR-3 that evaluated its selonsertib for patients with bridging fibrosis due to NASH did not meet the pre-specified week 48 primary endpoint.
The endpoint was for a histologic improvement in fibrosis of more than one stage without worsening of NASH.
Selonsertib is an investigational, once daily oral inhibitor of apoptosis signal-regulating kinase 1.
Out of the 802 patients enrolled in the study, 9.3 percent of patients treated with selonsertib 18mg and 12.1 percent of patients treated with selonsertib 6mg achieved the primary endpoint compared to 13.2 percent with placebo.
Why It's Important
NASH has no approved drug treatment and therefore offers huge potential for the first mover. Intercept Pharmaceuticals Inc ICPT has an edge.
Following the release of the STELLAR-4 results, Raymond James analyst Steven Seedhouse said Intercept's Ocaliva is on track to launch in NASH unencumbered by competition.
In February, Intercept reported positive late-stage results for its NASH candidate and subsequently presented additional positive results at the EASL annual meeting in Vienna.
What's Next
Gilead said it will now work with the Data Monitoring Committee and investigators to conclude the STELLAR-4 study.
"We believe that effective therapy for NASH will ultimately require a combination approach that targets distinct pathways involved in the pathogenesis of this disease," said John McHutchison, Gilead's head of R&D.
"In this regard, we look forward to data from the Phase 2 ATLAS combination trial of selonsertib, cilofexor and firsocostat in patients with advanced fibrosis due to NASH, which will be available later this year."
Gilead shares were trading up slightly at $62.81 at the time of publication Thursday.
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