danirixin

	Next higher product group	respiratory drug_o
	Status	2017-11-27 development p2 existent
	Organisation	GlaxoSmithKline plc (LSE: GSK, NYSE: GSK)
	Today	GSK plc (LSE: GSK, NYSE: GSK)
	Group	GSK (Group)

Owlstone Medical Ltd.. (11/27/17). "Press Release: Owlstone Medical’s Breath Biopsy Platform Integrated into GSK’s Phase II Respiratory Disease Clinical Trial". Cambridge.

Owlstone Medical, a diagnostics company developing a breathalyzer for disease, today announced that GSK, a world leader in respiratory, will incorporate Owlstone Medical’s Breath Biopsy platform into the clinical development programme of danirixin one of the novel drug candidates in its respiratory disease pipeline. The deal with GSK is a further important step in Owlstone Medical’s strategy to build a significant precision medicine business based on its Breath Biopsy® platform, which by analyzing biomarkers from breath, has the potential to generate data needed to improve clinical outcomes and reduce healthcare costs.

GSK will use Owlstone Medical’s Breath Biopsy platform as part of a Phase II clinical trial to assess whether the right patient for the right treatment can be identified, as well as assessing the treatment effects of a novel drug for chronic obstructive pulmonary disease (COPD). The platform will be used to capture Volatile Organic Compounds (VOCs) in breath completely non-invasively, and analyze them with high sensitivity. The breath samples will be collected from patients participating in the clinical trial using Owlstone Medical’s CE-marked ReCIVA Breath Sampler, before shipping to the company’s clinical lab for analysis.

Each exhaled breath contains a rich spectrum of VOCs produced by the body’s metabolism that relate directly to disease activity, and when analyzed can provide important insights for patient stratification. In addition, a patient’s VOC profile in breath can be modified by introducing external factors including therapeutic interventions, which on analysis could also provide valuable information about the therapeutic effects of the drug being assessed.

329 million people suffer from COPD worldwide, and a further 235 million suffer from asthma.

Owlstone Medical has established the world’s first Breath Biopsy clinical laboratory, enabling clinical and pharmaceutical partners to access comprehensive VOC biomarker discovery services and identify breath biomarkers for a range of precision medicine applications.

Billy Boyle, co-founder and CEO at Owlstone Medical, commented: "We are very pleased to work with GSK as they lead the way in using breath VOC profiling to better understand a new drug’s treatment effects and its mechanism. Our growing precision medicine business not only provides opportunities for near term revenue expansion, but also deepens the pipeline of applications for Breath Biopsy. We believe that the non-invasive Breath Biopsy can rapidly establish a central role in a variety of precision medicine applications such as patient stratification and monitoring treatment response. We intend to work with multiple pharmaceutical partners looking to optimize the health economic impact of their new medicines across a broad range of diseases by providing access to the data needed to ensure that the right therapy is given to the right patient at the right time."

Dr. Ruth Tal-Singer, VP, Medicine Development Leader and GSK Senior Fellow, Respiratory R&D GSK, said: "As part of our efforts to identify the right patient for the right treatment, we are pleased to include Breath Biopsy for the first time in one of our clinical trials. We hope that exploration of volatile compounds in breath will provide a tool to identify COPD patients who could benefit most from our medicines. We look forward to analyzing the results generated from Breath Biopsy when available."

ENDS

Notes to Editors

[Photo] ReCIVA
For a high resolution image please contact sarah.jeffery@zymecommunications.com

Media contact

For more information please contact:

Sarah Jeffery, Zyme Communications
sarah.jeffery@zymecommunications.com
+44 (0)7771 730919

IR contact

For more information please contact:
David Dible, Citigate Dewe Rogerson
david.dible@citigatedewerogerson.com

About Owlstone Medical

Owlstone Medical has developed a breathalyzer for disease. With a focus on non-invasive early detection and precision medicine for cancer, inflammatory disease and infectious disease, the company aims to save 100,000 lives and $1.5B in healthcare costs.

Owlstone Medical’s Breath Biopsy® platform is a new diagnostic modality capable of detecting disease biomarkers in breath. The award winning ReCIVA Breath Sampler ensures reliable collection of breath samples. VOC (Volatile organic compound) biomarkers present in breath are analyzed with high sensitivity and selectivity using proven microchip chemical sensor technology (Field Asymmetric Ion Mobility Spectrometry, FAIMS).

The Breath Biopsy platform has the potential to revolutionize early detection and precision medicine, with applications in cancer and a wide range of other conditions. Breath Biopsy enables disease to be detected earlier, when treatments are more effective and more lives can be saved. By identifying patients most likely to respond to a particular therapy, Breath Biopsy can also ensure that the right therapy is given to the right patient at the right time, helping to reduce healthcare costs.

Owlstone Medical is currently developing tests for lung and colorectal cancer, two of the most common cancer killers worldwide, and for asthma stratification by therapeutic response. The company also provides Breath Biopsy products and services to academic, clinical and pharmaceutical partners who want to develop breath based biomarkers for their own applications.

Owlstone Inc was founded in 2004 as a spin-out from the Engineering Department at the University of Cambridge, and is a profitable business selling FAIMS technology to military and industrial customers globally. Owlstone Medical was spun out from Owlstone Inc in 2016 to develop and commercialize FAIMS in medical applications.

Owlstone Medical is headquartered in Cambridge, UK, with offices in London, UK.