On the heels of Gilead’s (NYSE: GILD) disappointing phase 3 data readout in compensated cirrhosis from NASH (F4); Intercept Pharmaceutical (NYSE: ICPT) announced today positive results from their pivotal phase 3 study in patients with fibrosis from NASH. ICPT is up over 20% pre-market
A key difference between the studies is the mechanism of action of the respective drugs (ASK1 Inhibition and FXR agonists) and patient demographics. It seems that past the F3 stage it is difficult to achieve a clinically meaningful and statistically significant reduction in fibrotic staging without worsening of NASH, as we saw in STELLAR-4. ICPT’s obeticholic acid (OCA) 25 mg demonstrated that through agonism of the FXR nuclear receptor in liver cells it is possible to achieve this endpoint in F2-F3 stage NASH patients.
OCA achieved its endpoint of improving fibrosis by at least one stage with no worsening of NASH in a dose-dependent manner (i.e. 17.6% in OCA 10 mg group vs. 23.1% in OCA 25 mg group). Only in the OCA 25 mg group was the primary endpoint reached by reversing NASH fibrosis staging in conjunction with NASH resolution. This is a huge success and opens the door to a large market. Cudos to ICPT.
However, it is not the only NASH market up for grabs. A phase-3 trial has yet to show a statistically significant and clinically meaningful improvement in compensated (F4) or decompensated (F6) NASH-cirrhosis. Galectin Therapeutics (Nasdaq: GALT) could be the first to accomplish the former once they get their phase 3 trial off the ground, which is approved by the FDA to be done in patients without varicies. Conatus pharmaceutical (Nasdaq:
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