The phase II respiratory disease clinical trial will analyse breath biomarkers to improve understanding of the treatment effects of a novel GlaxoSmithKline (GSK) pipeline drug candidate for chronic obstructive pulmonary disease (COPD)
Owlstone Medical, a diagnostics company developing a breathalyser for disease, announced GSK, 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 analysing 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 COPD.
The platform will be used to capture volatile organic compounds (VOCs) in breath completely non-invasively and analyse 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 analysed 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, said: “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 optimise 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 of 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 analysing the results generated from Breath Biopsy when available.”