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Shire's SHP625 Fails in Phase II, FDA Accepts Lifitegrast NDA - Analyst Blog

Shire plc SHPG announced disappointing results from the phase II trial IMAGO on pipeline candidate SHP625 (formerly LUM001).

The trial did not meet its primary or secondary endpoints. The study was conducted among 20 pediatric patients suffering from Alagille syndrome (ALGS).

The primary endpoint was the change from baseline in serum bile acid levels as compared to placebo.

Data from the study showed that mean serum bile acid levels and pruritus at the end of the study were lower in both SHP625 and placebo treated groups as compared to baseline. Nevertheless, a positive correlation between percent changes from baseline in serum bile acid levels and pruritis was observed in the SHP625-treated group as the placebo arm was too small to make an accurate assessment of this relationship.

However, adverse events were recorded to be more frequent with SHP625 than with placebo.

Meanwhile, Shire is also evaluating SHP625 in progressive familial intrahepatic cholestasis, primary biliary cirrhosis and primary sclerosing cholangitis. Concurrent to IMAGO, Shire is conducting two larger placebo-controlled phase II studies on SHP625 for the treatment of ALGS.

The candidate enjoys orphan drug designation both in the U.S. and the EU. Shire repositioned its business in 2013, undertaking a realignment program with strategic focus on rare diseases.

SHP625 was added to Shire’s pipeline through the acquisition of Lumena Pharmaceuticals, Inc. in Jun 2014. The acquisition also added SHP626 (formerly LUM002) to Shire’s pipeline, which is ready to enter phase Ib studies in the first half of 2015 for the treatment of nonalcoholic steatohepatitis. Both compounds are inhibitors of the apical sodium-dependent bile acid transport.

This disappointment was however, overshadowed when the company received news of the FDA accepting its new drug application for ophthalmology candidate lifitegrast and granting a priority review designation. The candidate is being evaluated for dry eye disease in adults. The FDA will provide a final decision by Oct 25, 2015.

Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Actavis plc ACT, ArQule, Inc. ARQL and Valeant Pharmaceuticals VRX. All three carry a Zacks Rank #2 (Buy).

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