Intercept Pharmaceuticals Announces 2 New Sub-Groups For FLINT Trial

Intercept Pharmaceuticals Inc (NASDAQ:ICPT) is a biopharmaceutical company known for developing drug treatments for chronic liver diseases. The company’s current leading drug is obeticholic acid (OCA). OCA is used to treat Primary Biliary Cirrhosis (PBC), portal hypertension, bile acid diarrhea, and nonalcoholic steatohepatitis (NASH).

On March 20th, Intercept announced 2 new findings from subgroups in the Phase 2b FLINT trial of OCA in patients with NASH: efficacy in high-risk patients, and characterization of effects on cardio metabolic parameters.

The efficacy in high-risk patients’ sub-group monitored patients who had beginning to advanced stage of fibrosis, concomitant diabetes, obesity, or elevated ALT. Intercept found that the condition of patients with NASH and liver fibrosis treated in this sub-group improved. Obese patients with fibrosis and diabetes also treated with OCA showed signs of improvement. Furthermore, fewer patients being treated with OCA revealed signs of fibrosis progression.

The study of the subgroup consisting of patients who experienced cardio metabolic abnormalities showed improvement as well. The treatment, which lasted 72 weeks, showed improvement in patients with liver fibrosis and other abnormalities that lead to cardiovascular risk.

The analysis also monitored the effect of statin use in patients during FLINT, which revealed a accelerated reversal of their observed mean LDL increase to under baseline levels. David Shapiro, M.D., Chief Medical Officer of Intercept said, “Given the relatively high risk of progression to cirrhosis and mortality in this population of NASH patients with liver fibrosis and other co-morbidities, the findings being presented at the AASLD Colloquium add important new insights into the potential for OCA as a novel therapy to address a major unmet medical need… In addition to the histologic improvements in fibrosis and steatohepatitis seen in patients most at risk of progressing to cirrhosis, we are encouraged by the observation that OCA improved several important cardio metabolic parameters. Furthermore, the data support the potential for statins to effectively manage LDL and further improve liver enzymes, providing additional support for their use in NASH patients as currently recommended in the AASLD and EASL practice guidelines.”

According to SmarterAnalyst, Needham analyst Alan Carr reiterated a Buy rating on Intercept Pharmaceuticals with a $500 price target on March 23rd. He noted, “We believe the stock is undervalued given proximity to OCA commercialization in PBC and scale of commercial opportunity in NASH.”



Alan Carr has rated Intercept 7 times since August 2013, earning a 57% success rate recommending the company and a +78.2% average return per recommendation. Overall, he has a 74% success rate recommending stocks and a +43.6% average return per recommendation.

Separately on March 23rd, Leerink Swann analyst Joseph Schwartz maintained a Market Perform rating on Intercept with a price target of $265. He noted, “There is clear consensus among KOLs that OCA’s mechanism on lipid/CV profile is largely unclear, in particular in 3rd cohort where concerns were raised on LDL increases in pts who had always been on statins which may raise a few eyebrows at FDA, which was unfortunately absent from the mtg.”



Joseph Schwartz has rated Intercept 3 times since August 2014 with a 0% success rate and a -37.5% loss per recommendation. Overall, he has a 67% success rate recommending stocks and a +32.4% average return per recommendation.

On average, the top analyst consensus for Intercept Pharmaceuticals on TipRanks is Strong Buy.
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