• First time the effect of OFEV^® is being explored on change of biomarkers reflecting the fibrotic process in the lungs
• INMARK™ will assess whether temporal changes in these biomarkers can predict the clinical course of IPF earlier
• Identifying biomarkers to predict the clinical course of IPF early in individual patients remains one of the most important challenges to improve overall patient management

INGELHEIM, Germany -- (BUSINESS WIRE) --

Boehringer Ingelheim today announces that the first patient has been enrolled in a new study, INMARK™, investigating the effect of OFEV^® (nintedanib) on changes in specific blood biomarkers. These changes in biomarkers indicate the excessive scarring (fibrosis) in the lungs of patients with idiopathic pulmonary fibrosis (IPF).

Biomarkers are measurable indicators of the presence or severity of a condition and used to monitor and predict the disease course of patients so that appropriate treatment can be planned. INMARK™ will measure changes in various extracellular matrix (ECM^*) turnover biomarkers already shown to predict disease progression in IPF patients. ECM turnover is part of healthy tissue maintenance. However uncontrolled or excessive turnover is a key driver for the structural changes seen in IPF lungs, leading to progressive scarring and loss of lung function.

IPF is a debilitating and fatal lung disease with a high mortality, which causes permanent scarring of the lung tissue and loss of lung function over time. Early initiation of treatment may be crucial to help slow disease progression. Recent advancements have been made in the management of IPF with the availability of specific antifibrotic drugs such as OFEV^®, which has been shown to slow disease progression by approximately 50% across three key studies. However despite these advances, physicians are still uncertain when to start treatment in individual patients. This is due to the unpredictability and differences in disease progression across patients with IPF and the lack of biomarkers to inform how the disease will progress in individual patients and who may respond best to treatment.

“The initiation of this new study marks a major milestone. The trial is of great scientific value in that it will provide better understanding of IPF and the value of nintedanib treatment in individuals with preserved lung function. Importantly this is the first time we are investigating the effect of any antifibrotic treatment on changes in specific biomarkers in IPF,” commented Dr Toby Maher, Consultant Respiratory Physician at the Royal Brompton Hospital in London, United Kingdom and principle investigator. “Being able to identify biomarkers that will predict how the disease will progress in a specific patient will allow physicians to start their patients on appropriate treatment at the earliest opportunity to help slow disease progression. It remains one of the most urgent challenges for effective management for IPF patients.”

Early diagnosis of IPF is critical to helping patients manage their condition. The median survival of IPF patients following diagnosis is just 2-3 years, underlining the importance of early and accurate diagnosis and the vital role of treatments to help slow disease progression. OFEV^® has been shown to slow disease progression with approximately 50% reduction in the decline of lung function across a broad range of IPF patient types.

Dr William Mezzanotte, Therapy Area Head, Respiratory Medicine, Boehringer Ingelheim, said: “In a disease that displays variable rates of progression, identification of biomarkers that could allow physicians to identify and monitor individual disease progression and treatment successes in patients with IPF is essential. We hope that the identification of these biomarkers, particularly early in the disease, has the potential to improve overall patient management and enable better delivery of patient care.”

INMARK™ is one of a number of new trials recently initiated by Boehringer Ingelheim to provide the scientific community with important information on the safety and tolerability of OFEV^® in combination with other drugs and across different patient populations. This is part of Boehringer Ingelheim’s continued commitment to tackling the global burden of progressive fibrotic lung diseases.

* The ECM is the network of proteins and carbohydrates that surround a cell and is part of all living tissues. As well as providing structural support for cells, the ECM supports a tissue’s division, growth and development. ECM turnover is part of healthy tissue maintenance. Assessment of ECM turnover may serve as biomarkers for disease activity and progression in IPF.

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Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/press-release/ipf-ofev-inmark-biomarker-trial

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Email: press@boehringer-ingelheim.com