Intercept’s Upcoming NASH Data Is A Major Pivotal Point

Intercept expects to report results from its phase 3 REGENERATE study using Ocaliva to treat patients with NASH fibrosis in Q1 of 2019.

Ocaliva has already been approved by the FDA as a combination with ursodeoxycholic acid to treat patients with PBC.

The NASH market is expected to reach $20 billion to $35 billion in the coming years.

Intercept acquired U.S. rights for a PPAR inhibitor known as Bezafibrate, which is first expected to be initiated in a combination study with Ocaliva to treat patients with PBC.

The acquisition of Bezafibrate by Intercept is a good move in that it will allow the drug to be explored alone or in combination with OCA to treat a range of liver diseases including NASH.

Recently, Intercept Pharmaceuticals (ICPT) provided an update for both its non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC) programs. The main portion of the update deals with Intercepts upcoming results from the phase 3 REGENERATE study which is treating patients with NASH fibrosis. This study is expected to be readout in Q1 of 2019 and good data will give Intercept a stronghold in the NASH space.

Phase 3 REGENERATE Study

The most important item, as noted above, is the upcoming results for the phase 3 REGENERATE study. This study was established to recruit up to 2,370 patients with F2/F3 NASH fibrosis. Patients were randomized to receive either 10 mg, 25 mg of Ocaliva or placebo. The goal of the study is to see if Ocaliva performs better from baseline to 18 months of treatment compared to placebo. One thing to point out is that the upcoming results in Q1 2019 is an interim analysis and in no way will be final data. However, investors are viewing this as a highly major event. That’s because if the primary endpoints are not established at the interim analysis, it could cause the stock to be cut in half by 50% or more. Intercept already has Ocaliva approved by the FDA to treat patients with PBC but in combination with ursodeoxycholic acid (UDCA). In other words, these were patients who either didn’t respond to UDCA treatment or who were not able to tolerate it. The market potential for PBC is large, but not as much as the NASH market. It is estimated that the NASH market could reach between $20 billion to $35 billion in the coming years. The REGENERATE study is far more important in terms of Intercept’s future. There are two primary endpoints for this study. The first primary endpoint is the amount of Ocaliva treated patients that achieve at least one stage of liver fibrosis improvement with no worsening of NASH compared to placebo. In addition, the proportion of Ocaliva treated patients that achieve NASH resolution with no worsening of liver fibrosis compared to placebo. The other primary endpoint involves all-caused mortality and related liver clinical outcomes. There are also a host of other secondary endpoints as well that may prove to be useful for analysis as well like resolution of fibrosis.

https://seekingalpha.com/article/4233519-intercepts-upcoming-nash-data-major-pivotal-point-success