Topic: fatty liver disease
The financing comes months after NorthSea enrolled the first NASH patient in the trial of its structurally engineered fatty acid icosabutate.
NASH has been among the closely watched indications in biotech since January 2014.
We may be nearing the first-ever approval for a NASH drug next year, but the road to approval is not getting easier.
Gilead's NASH prospects firsocotat and cilofexor failed to move the needle on liver scarring in a phase 2 study, on their own or in combination.
NGM Bio’s aldafermin is an engineered version of the hormone FGF19, which modulates two receptors: FGFR4, which regulates bile acid synthesis in the liver, and FGFR1c, a signaling receptor in body fat that regulates the creation of new fats, glucose management and body weight.
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.
Gilead’s selonsertib was among the front-runners of the NASH race until it failed in a pair of phase 3 studies. But selonsertib’s journey is far from over. The company is testing it alongside firsocostat and cilofexor, drugs it picked up from Nimbus Therapeutics and Phenex Pharmaceuticals, respectively, in a phase 2 study.
Allergan picked up its lead NASH program, cenicriviroc, in its 2016 acquisition of Tobira Therapeutics, just after it failed a phase 2b NASH study. With regulators’ support, Tobira retooled the endpoint for the phase 3 study, which Allergan is carrying forward.
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.
Based on promising results that validated the idea of inhibiting DGAT2 for the treatment of NASH, Pfizer is working on a follow-on candidate.