Keyword: Intercept Pharmaceuticals
NASH leaders weigh in on the need for a drug for the disease and the challenges in getting it to patients.
Novartis has two NASH prospects in phase 2. The first, tropifexor, is one of a crowd of FXR agonists, and the second, licogliflozin, is an SGLT1/2 inhibitor, which works by blocking the absorption and reabsorption of glucose—a mechanism familiar to diabetes that could make a dent in NASH.
Although Intercept’s OCA is on track to beat elafibranor to market, Genfit is hopeful its candidate could be better. For starters, it has a different mechanism: Elafibranor is a dual agonist of PPAR-alpha and PPAR-delta, a type of protein found inside cells that plays a role in cellular metabolism.
Intercept already sells obeticholic acid as Ocaliva for the treatment of primary biliary cholangitis; it earned the FDA nod for that liver disease back in 2016. Intercept submitted OCA for FDA approval in NASH in September and plans to follow up with a European Medicines Agency filing by the end of the year.
From Big Pharmas like Novartis and Gilead to liver specialists and one-asset biotechs, it seems like everyone in biopharma has some skin in the NASH game. This report examines the top prospects in the NASH pipeline, and why we even need a drug for nonalcoholic steatohepatitis in the first place.
What the NASH field needs, says Genfit CEO Pascal Prigent, is something like the Hb1Ac test for diabetes.
The trial narrowly hit its primary endpoint but tolerability concerns and doubts about differentation overshadowed the readout.
As Genfit hopes for phase 3 successes and filings for its liver disease drug, its CEO and co-founder Jean-François Mouney is stepping aside.
Already on the Euronext stock exchange, liver disease biotech GenFit has made the jump to the more lucrative Nasdaq with a $135 million IPO.
In a pivotal phase 3 study, Intercept Pharmaceuticals' obeticholic acid improved liver fibrosis without any worsening of NASH after 18 months.