How This Drug Candidate Could be a Winner in Gilead's Pipeline

How This Drug Candidate Could be a Winner in Gilead's Pipeline March 21, 2017
By Alex Keown, BioSpace.com Breaking News Staff

FOSTER CITY, Calif. – Gilead Sciences is watching its hepatitis revenue streams dwindle due to a declining patient population, the company could see dollar signs of life in its Nonalcoholic Steatohepatitis pipeline–at least that’s what analysts from Jeffries are thinking.

For months, analysts have been crying out for Gilead to bolster its long-term revenue growth through aggressive M&A activity. Last year, Gilead’s Chief Executive John Miligan said he was eying some growth opportunities, particularly in the oncology, inflammatory diseases and liver disease fields. But so far Gilead has been unwilling to use its resources to acquire another company or new assets. And, if Brian Abrahams and his team at Jeffries are correct, that may be because the company is looking inward for new growth and relying on its own developmental therapies. Abraham identified GS-0976, part of the company’s Acetyl-CoA Carboxylase (ACC) inhibitor program, as a potential source of new revenue.

“Based on an EASL title posted in recent weeks but we believe not broadly discussed, ACC inhibitor GS-0976–one of GILD’s least-talked-about assets in NASH, in our opinion–appears to have demonstrated significant positive effects in the as-yet-unreported ph.II NASH study,” Abraham said in a note, according to a report in Barron’s.

Jeffries said the presentation title “Acetyl-CoA carboxylase (ACC) inhibitor GS-0976 leads to suppression of hepatic de novo lipogenesis and significant improvements in MRI-PDFF, MRE, and markers of fibrosis after 12 weeks of therapy in patients with NASH” is a strong indicator the drug will pan out favorably for the company.

Interestingly GS-0976 was not developed by Gilead, but acquired in early 2016. In April of that year, Gilead struck a $1.2 billion deal to acquire Cambridge, Mass.-based Nimbus Apollo, which developed GS-0976, formerly known as NDI-010976.

Not only does it seem to Abraham that GS-0976 is a strong asset for Gilead, he said the drug de-risks a second NASH asset for Gilead. Although he doesn’t mention any particular product, one Gilead NASH asset, selonsertib, an ASK-1 inhibitor, has had disappointing results. In November 2016, the company presented Phase II data that showed some troubles as both a monotherapy and in combination with simtuzumab, an investigational monoclonal antibody for NASH. Simtuzumab has also had a troubled history at Gilead, with the company ceasing several drug trials for various disorders. Selonsertib has not been a strong candidate for Gilead, having missed the mark in some Phase II trials, including the treatment of pulmonary hypertension and diabetic kidney disease.

Non-alcoholic steatohepatitis affects approximately 15 million people in the United States. NASH is a disease of the liver resulting from fat cells that can lead to inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. ACC inhibitors target a central cause of the disease—reducing aberrant lipid-derived signaling that can result in steatosis, inflammation and fibrosis. Gilead said NASH is expected to become the leading indication for liver transplantation by 2020.

For the past year, shares of Gilead have seen a steady decline. In April 2016, the stock was at a high of $102.29. Since then, it’s lost about half of its value. Today shares are trading at $67.91. Even if GS-0976 is successful, it might not be enough to stop the company’s stock decline. Writing in Barron’s, Ben Levisohn said he has already thrown in the towel on Gilead stock. He argued that not even an acquisition is likely to turn it around.

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