Intercept (ICPT) NASH Study to be Larger, Riskier and Delayed, Leerink Partners Says
Leerink Partners analyst Joseph Schwartz weighed in on Intercept Pharmaceuticals (NASDAQ: ICPT) after the company announced the design of Ph.3 REGENERATE study to evaluate the impact of obeticholic acid (OCA) treatment on non-alcoholic steatohepatitus (NASH) with fibrosis, after receiving final harmonized guidance from FDA and EMA. Schwartz said the study will be larger, riskier and take longer compared to Street estimates.
Schwartz commented, "As previously guided by ICPT, total trial population of F2/3 and high-risk F1s (with concomitant diabetes, obesity, etc.) does mimic the one that received breakthrough therapy designation; however this revised study design considers the latter set as exploratory population and will be excluded from the primary endpoint analysis."
He notes the oo-primary endpoint at IA to include NASH resolution (w/o fibrosis worsening) and improvement in fibrosis (w/o NASH worsening) is a significantly high bar that was met in the FLINT trial. "There exists no 'apples to apples' comparison to these two endpoints that may be teased out from FLINT datasets. Notably, the pre-specified analysis on NASH resolution did fail to hit statistical significance at first in overall FLINT trial (22% OCA vs. 13% placebo) , which later in a post-hoc analysis was shown to be statistically improved when looking at high-risk NASH patients (18% vs. 5%). It is unclear from the data cuts published to date, if these patients were also the ones that showed no worsening of fibrosis. OCA's effect on fibrosis improvement (39% OCA vs. 18% placebbo) was unequivocal in FLINT and that may bode well for OCA; however again it is unclear from our perspective if this analysis included all patients that had no worsening of NASH resolution."
The analyst added, "With little color provided by mgmt. on design and statistical analysis of the trial, in particular, the expected rate of liver and overall event rates in placebo and drug arms, investors may continue to question through the course of the study the powering assumptions in place that are required to rule out the risk of CV-related events. Mgmt. mentioned in the conference call that safety analyses includes close monitoring of MACE events, LDL, etc. We continue to believe that it is logical to place some weight on a scenario of imbalance (in spite of low events) may trigger study termination or enlargement similar to FLINT."
OCA's launch in NASH now expected in late 2018 at best, slightly delayed versus most Street models.
price target of $265.00
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Shares of Intercept Pharmaceuticals closed at $313.98 yesterday.