Intercept Pharmaceuticals (ICPT) Bullish Stance Reiterated at Wedbush Amid Trial Design
Wedbush analyst Liana Moussatos reiterated an Outperform rating and $493 price target on Intercept Pharmaceuticals (NASDAQ: ICPT) after the company announced the pivotal Phase 3 (REGENERATE) trial design testing OCA treatment of NASH patients with fibrosis (stages 2 & 3), with initiation planned for Q3. Based on FLINT, they believe NASH Phase 3 is achive for OCA for a barrier for competition.
Moussatos commented, "The disclosed trial design includes a double blind, placebocontrolled pivotal Phase 3 trial expected to enroll up to ~2,500 NASH patients with stage 2 or 3 fibrosis at ~250 centers in the U.S., EU and other regions. (In addition, a separate small group of NASH patients will be enrolled with stage 1 early fibrosis with an increased risk of rapid progression due to concomitant diabetes, obesity or acute liver inflammation (defined by elevated ALT). However, this cohort will not be included in the primary endpoint analysis. Patients will be randomized 1:1:1 to receive placebo, 10mg of OCA or 25mg of OCA as a single table once daily. The trial is designed to include a pre-planned interim look at histology in ~1400 patients after 72-weeks, after the interim look that trial will remain blinded and continue to track patients until a pre-specified number of liver-related AEs occur. The interim look is expected to serve as the basis for accelerated approval in the U.S., EU and other international markets and the endpoints have been harmonized among the regulatory agencies. The interim analysis at 72 weeks will evaluate the co-primary endpoints: (1) the proportion of OCAtreated patients relative to placebo achieving at least one stage of liver fibrosis improvement with no worsening of NASH, and (2) the proportion of OCA-treated patients relative to placebo achieving NASH resolution with no worsening of liver fibrosis. We note all liver histological parameters will be assessed using central read which should reduce variability. Given these primary endpoints, we believe the Phase 2 FLINT data are supportive of success for the trial. Management commented that a subanalyses of the FLINT fibrosis stage 2 and 3 patients (similar to the Phase 3 patients) using the Phase 3 co-primary endpoint definitions showed the proportion of these patients demonstrating an improvement in fibrosis without NASH worsening was 43% (OCA treated) and 14% (placebo) and 14% OCA treated patients achieved NASH resolution without worsening of fibrosis versus 3% (placebo). We believe the positive results from FLINT reduce clinical risk for OCA in the Phase 3 NASH trial. The Phase 3 trial is expected to initiate in Q3:15. As we expected, a cardiovascular outcome trial (CVOT) will not be needed for accelerated approval. Management noted that patient lipid profile will be aggressively monitored and the initiation of statins will occur as necessary."
Intercept has upped the bar for approval in NASH, the analyst said. "We believe the co-primary endpoints of NASH resolution and fibrosis improvement are likely to make it difficult for companies’ with product candidates that have yet to show an improvement in liver fibrosis get approval. Additionally, we believe that the large trial size serves as barrier for approval for other companies seeking approval of product candidates in NASH."
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Shares of Intercept Pharmaceuticals closed at $313.98 yesterday.