GlaxoSmithKline plc (LSE/NYSE: GSK) will share new evidence from the pivotal CAPTAIN study exploring the potential for a biomarker-directed approach to determine appropriate inhaled therapy for patients with uncontrolled asthma.

The new sub-analyses will be amongst a range of abstracts GSK is presenting at the American Thoracic Society (ATS) Virtual Conference, 5-10 August 2020, advancing its increasingly personalised approach towards asthma management.

Scientific understanding of the heterogenous nature of asthma is growing, and evidence now suggests that identifying specific 'treatable traits' in patients could help predict their response to different types of inhaled therapy, helping healthcare professionals select the right treatment for the right patient.

The CAPTAIN study was designed to evaluate once-daily single inhaler triple therapy as a treatment for adults whose asthma is inadequately controlled despite treatment with maintenance asthma medication. The analyses being presented at ATS provide new insights on triple therapy and the movement towards personalised treatment.

Christopher Corsico, Senior Vice President Development, GSK commented, 'The need for a more targeted, personalised and proactive approach in asthma management is clear. Many patients continue to suffer with avoidable symptoms of their disease. The data we are sharing at ATS explore the specific characteristics that may help determine treatment options for these patients, such as increasing bronchodilation or further reducing inflammation. Progressing towards an increasingly personalised approach has the potential to reshape the asthma treatment paradigm and ultimately improve patient outcomes.'

GSK has been a leader in establishing a targeted approach to the management of patients suffering with severe asthma through the use of biomarkers such as eosinophil counts. In line with efforts to further advance eosinophil science, GSK will also share new data on its targeted biologic therapy, Nucala (mepolizumab). Results from the COMET study, which explored outcomes in patients with severe eosinophilic asthma after continuing or stopping Nucala following long-term treatment, will be shared for the first time, as will data from the pivotal phase 3 trial in hypereosinophilic syndrome (HES), a rare but severe eosinophil-driven disease. Nucala is not yet approved for use in HES anywhere in the world.

Reinforcing the need for further research and new treatment options, data will also be presented on the burden of asthma looking at the proportion of patients with sub-optimal levels of asthma control.

About asthma and severe eosinophilic asthma

Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms impacting their daily lives.

The causes of asthma are not completely understood but likely involve an interaction between a person's genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming 'uncontrolled' or which remains 'uncontrolled' despite this therapy.

Severe asthma patients are also often categorised by long-term use of oral corticosteroids (OCS). In a sub-set of severe asthma patients, the over-production of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs. Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival and provides an essential signal for the movement of eosinophils from the bone marrow into the lung. Studies suggest that approximately half of patients with severe asthma have eosinophilic airway inflammation.

About the CAPTAIN Study

CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) was a randomised, double-blind, active controlled, six-arm parallel group, global multicentre study evaluating FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to adults aged 18 and older whose asthma was inadequately controlled despite treatment with ICS/LABA (>250 mcg/day fluticasone propionate, or equivalent) maintenance asthma medication. In the study 2,436 patients were treated across 15 countries.

About Trelegy Ellipta (FF/UMEC/VI) in the US

FF/UMEC/VI is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day. It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK's Ellipta dry powder inhaler.

FF/UMEC/VI was approved in the US under the brand name Trelegy Ellipta in September 2017 for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm or for the treatment of asthma. US Prescribing Information for Trelegy Ellipta. An sNDA for FF/UMEC/VI for the treatment of asthma in adults was submitted to FDA in October 2019.

About Nucala

First approved in 2015 for severe eosinophilic asthma (SEA), mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils reducing blood eosinophils to normal levels. The mechanism of action of mepolizumab in asthma has not been definitely established. At normal levels eosinophils may play a role in maintaining health.

Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been studied in over 3,000 patients in 21 clinical trials across a number of eosinophilic indications and has been approved under the brand name Nucala in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with SEA. It is approved for paediatric use from ages six to 17 in Europe and the US and several other markets in SEA. In the US, Japan and Canada and a number of other markets, it is approved for use in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Regulatory submissions for Hypereosinophilic Syndrome and chronic rhinosinusitis with nasal polyps are expected to progress in 2020. Mepolizumab is also being investigated for COPD. Mepolizumab is not yet approved for use in HES, chronic rhinosinusitis with nasal polyps or COPD anywhere in the world.

Mepolizumab is not approved for the relief of acute bronchospasm or status asthmaticus. Full US Prescribing Information is available at US Prescribing Information Nucala.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.

Contact:

Simon Steel

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk Factors' in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

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