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Intercept Reports Phase III Sub-Study Liver Biopsy Data


Intercept Pharmaceuticals ICPT announced encouraging data from the POISE biopsy sub-study. Results from the study confirmed that long-term treatment with obeticholic acid (“OCA”) leads to the reversal or stabilization of fibrosis/cirrhosis in patients with primary biliary cholangitis (“PBC”) who have had an incomplete response to ursodeoxycholic acid (UDCA).

Shares of the company fell 32.7% compared with the industry’s decline of 8.1%.

The study showed that some patients who were treated with OCA had regression of fibrosis and even cirrhosis. The study showed that OCA leads to significant reductions in alkaline phosphatase (ALP)-the primary endpoint, that are predicted to improve clinical outcomes of patients with PBC who do not respond adequately to or do not tolerate UDCA. The majority (97%) of the patients who completed the double-blind phase of the POISE trial entered an open-label extension.

In the sub-study of the POISE phase III trial, paired biopsies adequate for analysis were obtained for 13 patients all of whom had liver fibrosis or cirrhosis at baseline. Prior biopsy studies have shown that patients who were not treated with, or have an inadequate response to UDCA — which is the current standard of care — are at significantly higher risk of fibrosis progression, liver failure, transplant and death. However, results from the study showed that 13 patients — all receiving treatment with UDCA at baseline — had paired biopsies that were adequate for analysis.

After three years of OCA treatment, majority of patients improved (n=6; 46%) or maintained (n=5; 38%) their histological stage, while two patients (15%) deteriorated. Of the four patients with baseline cirrhosis, three (75%) improved to fibrosis without cirrhosis while receiving OCA treatment.

Pruritus is the most common symptom in patients with PBC and was also the most common adverse event in the POISE phase III sub-study.

The company also looks forward to announcing the results of the phase IV COBALT study to further evaluate OCA’s effects on fibrosis regression and clinical outcomes in patients with PBC.

Zacks Rank and Stocks to Consider

Intercept carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the same space worth considering are Ligand Pharmaceuticals LGND, Protagonist Therapeutics PTGX and Catabasis Pharmaceuticals CATB. Whlle Ligand and Protagonist sport a Zacks Rank #1 (Strong Buy), Catabasis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings per share estimates have moved up $3.78 to $4.40 from $4.75 to $5.32 for 2018 and 2019, respectively, over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 57% over a year.

Protagonist’s loss estimates narrowed from $1.30 to 66 cents for 2018 and from $1.99 to $1.26 for 2019, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.95%.

Catabasis’ loss estimates narrowed from $1.09 to 92 cents for 2018 and from $1.76 to $1.48 for 2019, in the last 30 days. The company came up with a positive earnings surprise in all the preceding four quarters, with an average beat of 14.56%. The stock has rallied 23.9% so far this year.

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