Intercept (ICPT) Posts New Positive Results on NASH Drug

Intercept Pharmaceuticals, Inc. ICPT announced new positive data on obeticholic acid (OCA) for the indication of nonalcoholic steatohepatitis (NASH) from the late-stage study REGENERATE at the virtual International Liver Congress 2020, the 55th Annual Meeting of the European Association for the Study of the Liver (EASL).

Data showed that OCA helped NASH patients achieve sustained improvements in liver biochemistry and noninvasive markers of liver fibrosis over two years of treatment.

We note that REGENERATE is a phase III, randomized, double-blind, placebo-controlled, multicenter study, assessing the safety and efficacy of OCA for clinical outcomes in patients with liver fibrosis due to NASH. A pre-specified 18-month analysis was conducted to analyze the effect of OCA on liver histology comparing month-18 biopsies with baseline.

The study completed the target enrollment of the clinical outcomes cohort with 2,480 adult NASH patients randomized at more than 300 qualified centers worldwide and is expected to continue through favorable clinical results for verification and description of clinical benefits. The end-of-study analysis is designed to evaluate the effect of OCA on all-cause mortality and liver-related clinical outcomes as well as long-term safety.

Per management, this new set of data provides further evidence that OCA can help patients with advanced fibrosis due to NASH to halt or reverse the progression to cirrhosis.

Earlier, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement (≥1 stage) with no worsening of NASH at the planned 18-month interim analysis of REGENERATE with high statistical significance. The new program included patients from the interim analysis intent-to-treat (ITT) population, randomized early enough to have both evaluable month-18 biopsies and month-24 data at the time of the interim study. Data further showed that mean values of transaminases and other serum-based tests improved rapidly in patients treated with OCA and were sustained beyond 18 months of therapy compared to placebo.

Overall, the new data suggests that treatment of longer duration with OCA will likely result in greater fibrosis reduction beyond 18 months.

In June 2020, the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for OCA to treat fibrosis due to NASH. The CRL for OCA was disappointing as Intercept’s OCA was a frontrunner in receiving a regulatory approval for the treatment of NASH.

A potential nod would have significantly boosted Intercept’s prospects as OCA could have been one of the first therapies approved for the treatment of NASH.

Shares of Intercept have slumped 60.6% in the year so far against the industry’s growth of 1%.


Even though the NASH market promises potential, it is quite challenging at the same time. Earlier, France-based Genfit GNFT announced disappointing results from the RESOLVE-IT phase III study, evaluating the once-daily, 120mg of elafibranor in adults with NASH.

Meanwhile, Viking Therapeutics VKTX is evaluating VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist in a phase IIb study for the treatment of biopsy-confirmed NASH and fibrosis. This apart, clinical-stage biopharmaceutical company Galmed Pharmaceuticals Ltd. GLMD is developing Aramchol, a liver targeted, oral SCD1 modulator for patients with NASH and fibrosis.

Intercept currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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