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Intercept Pharmaceuticals Reports Phase III Data on Ocaliva

Intercept Pharmaceuticals, Inc. ICPT announced results from new analyses on the phase III trial, POISE, on its lead pipeline candidate, Ocaliva, at the 51st Annual Meeting of the European Association for the Study of the Liver (EASL).

The candidate is being evaluated for the treatment of primary biliary cholangitis (PBC).

We note that ursodeoxycholic acid (UDCA) is the only drug currently approved in the U.S. for the treatment of PBC. Data from the study analyzed a risk model to predict estimated liver transplant-free survival of patients enrolled in the trial and assessed a titration strategy for managing treatment-related pruritus. Researchers from Erasmus University Medical Center applied a risk model developed by the Global PBC Study Group to observe liver transplant-free survival in patients treated with Ocaliva against placebo.

Of the total patient population, 93% continued to receive UDCA upon initiating Ocaliva or placebo. The model showed that patients treated with Ocaliva and UDCA had significantly improved estimated liver transplant-free survival compared to the group treated with placebo and UDCA.

Meanwhile, data from the trial also examined the titration strategy used to address treatment-related pruritus. Data showed that initiating Ocaliva at 5 mg and titrating up to 10 mg based on clinical response at six months helped mitigate both the incidence and severity of pruritus.

Last week, the FDA’s Gastrointestinal Drugs Advisory Committee voted unanimously (in the ratio of 17 to 0) in favor of Ocaliva. The PDUFA date is scheduled for May 29, 2016.

A potential approval of Ocaliva in May 2016 should boost the growth potential of the company substantially.

Intercept Pharma currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Novo Nordisk A/S NVO, Eli Lilly and Company LLY and Johnson & Johnson JNJ. All the three stocks carry a Zacks Rank #2 (Buy).

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