Gilead (GILD) Announces Top-Line Results From NASH Study

Gilead Sciences, Inc. (NASDAQ:GILD) announced mixed top-line results from the mid-stage study on combination and monotherapy investigational treatments for advanced fibrosis (F3-F4) due to nonalcoholic steatohepatitis (NASH).

The 48-week, phase II ATLAS randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of monotherapy and dual combination regimens of the nonsteroidal farnesoid X receptor (FXR) agonist cilofexor 30 mg, the acetyl-CoA carboxylase (ACC) inhibitor firsocostat 20 mg and selonsertib 18 mg in patients with advanced fibrosis (F3-F4) due to NASH.

The results showed that the investigational regimens did not lead to a statistically significant increase in the proportion of patients who achieved the primary efficacy endpoint of a ≥1-stage improvement in fibrosis without worsening of NASH.

Nevertheless, statistically significant improvements in multiple response measures of fibrosis and liver function were observed in patients treated with the combination of firsocostat and cilofexor compared with placebo.

Firsocostat, cilofexor and selonsertib, as monotherapies and dual combination regimens, were generally well tolerated.

We remind investors that the selonsertib monotherapy treatment group was discontinued following the termination of the STELLAR studies on the candidate. In February, Gilead announced that STELLAR-4, a phase III, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib in patients with compensated cirrhosis (F4) due to NASH, did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH. STELLAR-3, a phase III study evaluating the safety and efficacy of the drug in patients with bridging fibrosis (F3) due to NASH, also did not meet the pre-specified week 48 primary endpoint.

A chronic liver disease, NASH, is caused by excessive fat accumulation in the liver or steatosis. Per statistics, it affected up to 15 million people in the United States causing inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. With no treatments presently approved to address this disease, the market scope is substantially huge and many companies are investing a major chunk of their R&D budget in the same.

Gilead is advancing multiple investigational compounds for the treatment of advanced fibrosis due to NASH, evaluating single-agent and combination therapy approaches against the core pathways associated with NASH – hepatocyte lipotoxicity, inflammation and fibrosis. The company also collaborated with Novo Nordisk (NYSE:NVO) for a proof-of-concept study combining Gilead’s cilofexor and firsocostat and Novo Nordisk’s semaglutide (GLP-1 analogue) for the treatment of patients with NASH.

The frontrunner in the NASH space is Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) . Earlier this year, Intercept announced that the FDA accepted its New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of fibrosis due to NASH. The regulatory agency also granted Priority Review to the same. The authority assigned a Prescription Drug User Fee Act (PDUFA) target action date of Mar 26, 2020, to the NDA.

However, developing NASH treatments is a complex affair and there have been quite a few setbacks. CymaBay Therapeutics, Inc. (NASDAQ:CBAY) terminated its mid-stage study of seladelpar for NASH based on unfavorable outcomes.

Gilead’s stock has gained 5.7% in the year so far compared with the industry's growth of 7.2%.

The massive decline in sales of the HCV franchise has propelled the company to focus on its HIV franchise, Yescarta and other newer avenues for growth.

Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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