Investors are again infatuated with Intercept Pharmaceuticals (ICPT), which on Monday reported further results from a mid-stage study of drug candidate obeticholic acid. ICPT rocketed higher by 400% in January when the phase 2b FLINT trial was stopped early for efficacy, though reported lipid abnormalities, which surfaced days later, brought the stock back to earth. The top-line results on Monday assuage concerns that the lipid abnormalities might be prohibitive, and suggest that obeticholic acid has a good shot at success in a forthcoming phase 3 trial.
Some analysts are calling NASH a $5 billion opportunity.
In an SEC filing on Monday, Intercept reported that 46% of patients in the OCA treatment group and 21% in the placebo treatment group met FLINT’s primary histological endpoint – a decrease in the NAFLD Activity Score (NAS) of at least two points with no worsening of fibrosis (p < 0.001, n=219). More patients in the OCA treatment group also experienced improvements in NASH resolution (22% compared to 13% of patients) on placebo (p=0.09, n=200). 35% of OCA patients vs. 19% on placebo (p=0.01) saw a fibrosis improvement.
Most importantly, cholesterol changes (higher LDL and lower HDL) resolved when treatment was stopped after 72 weeks, and appear addressable on therapy.
ICPT climbed to $400 in after-hours trading on Monday, from $235, when the updated data were released, but retreated to below $300 in the Tuesday session.
