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Gilead NASH drug dead in the water as second Phase III trial fails

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A Phase III study of a drug developed by Gilead Sciences for nonalcholic steatohepatitis has failed, the company said Thursday.

The Foster City, California-based biopharma company said the study, STELLAR-3, testing the drug selonsertib against placebo, did not meet its primary endpoint of demonstrating an improvement by at least one stage in NASH patients with bridging fibrosis, also known as F3.

The trial’s failure was in line with analysts’ expectations following the failure of another Phase III trial, STELLAR-4, among patients with the more advanced F4 NASH, in February. At the time of the STELLAR-4 announcement, Gilead’s shares fell more than 4 percent. However, following Thursday’s announcement, the company’s share price appeared unaffected.

Cowen analyst Phil Nadeau wrote in a note to clients that the STELLAR-3 results were not surprising after the STELLAR-4 study’s failure, adding that physician key opinion leaders his firm had spoken to were universally skeptical of its chances of success. “Now that selonsertib has definitively failed in both F3 and F4 patients, it is clear it will have no role in the treatment of NASH,” he wrote.

Since the last announcement about selonsertib, Gilead has sought to tackle NASH through partnerships with other companies. Last week, it announced a partnership with South San Francisco, California-based Insitro to discovery and develop new drugs for NASH with the aid of the latter company’s machine learning system. That deal includes a $15 million upfront fee and up to $235 million in milestone payments. Less than a week before, Gilead announced a deal with Danish drugmaker Novo Nordisk to combine two Gilead drugs, the FXR agonist cilofexor and the ACC inhibitor firsocostat, with Novo Nordisk’s approved diabetes drug Ozempic (semaglutide).

The stakes in NASH are high. Currently, there is no Food and Drug Administration-approved drug for the disease, whose prevalence is rapidly rising around the world along with the rate of obesity and Type 2 diabetes. The company currently in the lead is New York-based Intercept Pharmaceuticals, which has announced positive Phase III data for its drug, Ocaliva (obeticholic acid), raising the prospects of the company becoming the first to win an FDA approval in NASH.

Photo: Sakramir, Getty Images

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