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Friday, February 15, 2019

Gilead: only a select few NASH drugs available for purchase?

Previous article forecast problems for selonsertib, as new research indicates that this drug targets mouse-specific pathways that are not present in humans.
NASH cirrhosis trials continue to struggle.
Intercept’s Ocaliva, a “NASH cirrhosis” drug candidate, is hailed as a Gilead’s acquisition target while fraught with serious adverse effects and long-term safety considerations.
My previous article forecast problems for selonsertib, as new research indicates that this drug targets mouse-specific pathways that are not present in humans. NASH cirrhosis trials continue to struggle. Intercept’s (NASDAQ:ICPT) Ocaliva, a “NASH cirrhosis” drug candidate, is hailed as a Gilead’s (NASDAQ:GILD) acquisition target while fraught with serious adverse effects and long-term safety considerations.

Introduction

In previous article, Update On NASH Antifibrotics: Allergan, Gilead, Conatus, Galectin, I speculated that Gilead Sciences’ selonsertib, an ASK-1 inhibitor for the treatment of NASH fibrosis and cirrhosis, may not work at all. Hepatocyte ballooning scores did not differ from control (simtuzumab) and a recent Hepatology Journal publication showed no MAPK pathway (the target of selonsertib) in multiple human liver biopsies. Gilead recently released terribly disappointing results for compensated cirrhosis patients, validating my recent forecast. However, detailed results from STELLAR-4 and top-line results from STELLAR-3, where patients have bridging fibrosis and not cirrhosis, will give insight as to whether the drug doesn’t work – or that it simply doesn’t work in cirrhosis. The latest research still suggests that it is a mouse drug, and if this is true, Gilead needs to acquire another NASH drug to “remain committed” to reaching the NASH market in a timely manner and become a NASH market leader. Will Gilead pursue another antifibrotic?

M&A Targets for Gilead

There are only a select few NASH drugs available for purchase that are practically close to commercialization. Among these drugs are (OTCPK:GNFTF) elafibranor, a dual PPAR alpha/delta agonist, and Madrigal Pharmaceuticals’ (MDGL) MGL-3196, a THR-beta agonist, both of which look very promising as metabolic targeting drugs for NASH. Then there is Intercept Pharmaceuticals’ Ocaliva, a semisynthetic bile acid FXR agonist, another metabolic and inflammation drug. Notably on the antifibrotic side, Allergan’s (AGN) cenicriviroc, a dual CCR2/5 inhibitor, and Conatus Pharmaceuticals’ (CNAT) emricasan, a caspase inhibitor, are likely not up for grabs because Allergan is a large cap that already acquired cenicriviroc from Tobira, and Conatus has a notable partnership with Novartis (NVS). So, from an antifibrotic standpoint, the only true antifibrotic NASH drug remotely nearing commercialization is Galectin Therapeutics’ (GALT) GR-MD-02, a galectin-3 inhibitor recently named belapectin.

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