Research Desk Line-up: China Pharma Post Earnings Coverage
LONDON, UK / ACCESSWIRE / September 14, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for GlaxoSmithKline PLC (NYSE: GSK) ("GSK"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=GSK. The Company announced on September 12, 2017, the publication of complete results from the phase-III studies for Mepolizumab in chronic obstructive pulmonary disease (COPD). The investigational clinical development program data highlights that treating eosinophilic COPD patients with the biologic medicine, Mepolizumab, in addition to maximal guideline-recommended therapy, lowers exacerbations in these difficult-to-treat patients. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Discover more of our free reports coverage from other companies within the Drug Manufacturers - Major industry. Pro-TD has currently selected China Pharma Holdings, Inc. (NYSE: CPHI) for due-diligence and potential coverage as the Company announced on August 15, 2017, its financial results for Q2 2017 which ended on June 30, 2017. Tune in to our site to register for a free membership, and be among the early birds that get our report on China Pharma when we publish it.
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Results Published in NEJM
Results of the Phase-3 METREX and METREO studies, along with data from a pre-specified meta-analysis that combines both studies, have been published in the New England Journal of Medicine (NEJM). Simultaneously, it has also been presented at the European Respiratory Society (ERS) International Congress 2017.
About Mepolizumab
Mepolizumab is a first-in-class monoclonal antibody which targets the signaling protein IL-5. Mepolizumab binds to IL-5, inhibiting it from binding to its receptor on the surface of white blood cells called eosinophils. Preventing IL-5 from binding to its receptor reduces blood eosinophils. Eosinophils are believed to play a key role in protecting the body against infections. However, for some, eosinophils can also cause inflammation and are involved in the development of some inflammatory diseases. Mepolizumab has been developed for the treatment of diseases caused by eosinophils inflammation.
Regulatory Filings In-Line for Mepolizumab
Steve Yancey, Vice President and Medicine Development Lead for Mepolizumab at GSK, shared his views about the publication. He said that the data publication at the NEJM signifies benefits of a personalized medicine approach in the treatment of COPD with Mepolizumab, using blood eosinophils as a biomarker. GSK intends regulatory filings for 2017, depending on the complete data, discussions with external experts, and the recognized unmet medical need in this patient population.
Exacerbation Reduction, a Breakthrough Outcome
Professor Ian Pavord, of the University of Oxford, stated that the exacerbation reduction shown in the METREX and METREO studies is a clinically significant outcome. He shared that for people living with COPD, an exacerbation leads to struggle in breathing despite receiving the available guideline recommended treatment and that currently, there are no other treatment options for these patients.
Phase-3 Study Design and Primary Endpoints
The phase-III studies weremulti-centre, randomized, placebo controlled, double blind, and parallel group design with treatment administered through subcutaneous (SC) injections every four weeks in COPD patients at high risk of exacerbations despite the use of optimal standard of care background therapy. The studies were designed for a period of 62 weeks, comprising of a 1-2 week screening period, a 52-week treatment period, and an 8-week follow-up period. These were basically designed with an aim to assess the efficacy and safety of Mepolizumab as add-on therapy in the reduction of moderate to severe COPD exacerbations in patients at high risk of exacerbations, and to identify the patients with COPD most likely to respond to treatment using blood eosinophil as a biomarker.
- The METREX study randomized 836 patients to assess Mepolizumab 100mg or placebo across a range of baseline blood eosinophil counts. Patients were stratified as per (i) blood eosinophil count of >150 cells/µL at study entry or >300 cells/µL within the past year (higher eosinophil group), or (ii) blood eosinophil count of <150 cells/µL at study entry and no evidence of >300 cells/µL within the past year. In case of patients with higher eosinophils, the primary endpoint was a statistically significant reduction in the frequency of moderate and severe exacerbations for Mepolizumab 100mg compared to placebo.
- The METREO study (117113) randomized 674 patients for a dose-ranging study. Patients with a blood eosinophil count of >150 cells/µL at study entry or >300 cells/µL within the past year (i.e. higher eosinophil group) were randomized to receive Mepolizumab 100mg, Mepolizumab 300mg, or placebo. For patients with higher eosinophils, the primary endpoint was a decrease in the frequency of moderate and severe exacerbations for Mepolizumab compared to placebo; this was however seen as not statistically significant.
Here, it is important to note that moderate exacerbations denote those requiring treatment with systemic corticosteroids and/or antibiotics while severe exacerbations were those requiring hospitalization or which resulted in death.
Study Results
- COPD patients with blood eosinophil counts of >150 cells/µL at study entry or >300 cells/µL within the past year treated with add-on 100mg Mepolizumab demonstrated a consistent reduction of 18% - 20% in the primary endpoint of annual rate of moderate and severe exacerbations.
- The reduction in the frequency of exacerbations observed in the METREX study was statistically significant (18%, p=0.036 after multiplicity adjustment).
- In METREO, the reduction was not statistically significant (20%, p=0.068 after multiplicity adjustment).
- The pre-specified meta-analysis assessed the association between screening blood eosinophil counts and treatment response. The analysis verified that rates of exacerbation reduction rose as blood eosinophil counts increased. This shows the relevance of blood eosinophils as a biomarker to help identify COPD patients who are most likely to respond to treatment with Mepolizumab.
- However, there was no evidence of greater treatment effect in patients treated with a higher (300mg) dose of Mepolizumab - as assessed in the dose ranging METREO study. In the METREX study, patients with blood eosinophil counts of less than 150 cells/µL at the start of the study (i.e. patients with non-eosinophilic COPD) were not found to benefit from Mepolizumab.
- For the secondary endpoints, there was a statistically significant increase in the time to first moderate and severe exacerbation in METREX, with numerical, but not a significant increase in time to first exacerbation in METREO. There were no significant differences between Mepolizumab and placebo in either study on the remaining secondary endpoints: i.e. annual rate of exacerbations requiring emergency department visit and/or hospitalization, St George's Respiratory Questionnaire score, and COPD assessment test score.
No New Safety Concerns
The data review from the studies highlighted no new safety concerns to the known safety profile of Mepolizumab. The faction of patients facing adverse events and serious adverse events while receiving treatment was similar for Mepolizumab and placebo.
Last Close Stock Review
On Wednesday, September 13, 2017, the stock closed the trading session at $40.10, marginally down 0.67% from its previous closing price of $40.37. A total volume of 2.72 million shares have exchanged hands, which was higher than the 3-month average volume of 2.65 million shares. GlaxoSmithKline's stock price advanced 2.79% in the last one month. Furthermore, since the start of the year, shares of the Company have gained 4.13%. The stock is trading at a PE ratio of 38.78 and has a dividend yield of 4.96%. The stock currently has a market cap of $97.78 billion.
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