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GlaxoSmithKline Initiates Phase III Study with Mepolizumab

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GlaxoSmithKline plc (GSK - Free Report) announced the initiation of a phase III study with Nucala (mepolizumab,) in patients with severe hypereosinophilic syndrome (HES). The 32 week study aims to randomize about 18-20 patients. The study will also assess the effects of mepolizumab 300 mg every four weeks compared with placebo in adolescent and adult patients with severe HES.

GlaxoSmithKline’s share price shows that the company has outperformed the Zacks classified Large Cap Pharmaceuticals industry year to date. The stock returned 9.4% compared with industry’s gain of 6%.

Mepolizumab is a humanized IgG1 monoclonal antibody specific for IL-5. It is approved, under the brand name Nucala, in the EU, the US and a number of other countries for use as an add-on treatment for patients with severe asthma, with an eosinophilic phenotype.

The primary endpoint of the study is the proportion of patients who experience an HES flare during the 32-week study treatment period. The secondary endpoint will demonstrate supportive evidence for the benefit of mepolizumab compared with placebo and include the proportion of patients who experience an HES flare during week 20 through week 32, and fatigue severity.

HES is a disease characterized by a persistently elevated eosinophil count in the blood affecting about 20,000 patients globally. We note that mepolizumab has been granted orphan drug status for the HES indication by regulatory authorities in the U.S. and the European Union.

In Mar 2017, GlaxoSmithKline announced that a phase IIIb MUSCA study showed that patients with severe asthma driven by eosinophilic inflammation when treated with the Nucala added-on to standard of care achieved clinically and statistically significant improvements in their health-related quality of life and lung function when compared with patients treated with placebo and standard of care. The study met all its primary and secondary endpoints.

Zacks Rank & Stocks to Consider

GlaxoSmithKline currently carries a Zacks Rank #3 (Hold). Some other better-ranked stocks in the health care sector include Heska Corp. , Retrophin, Inc. and Galena Biopharma, Inc. . All the three companies carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings estimates moved up from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 60 days. The company posted a positive earnings surprise in all of the last four quarters, with an average beat of 291.54%. Its share price increased 46.6% year to date.

Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.  

Galena Biopharma‘s loss estimates narrowed from $2.53 to 58 cents for 2017 and from $1.95 to 73 cents for 2018, over the last 60 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 53.83%.  

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