New Phase III study of nintedanib in people with systemic sclerosis and lung fibrosis

Ingelheim, Germany, 08 December 2015 – Boehringer Ingelheim announced today that the first person has been enrolled in the SENSCIS^™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS) study. The global Phase III trial, which is now open for recruitment, is investigating the efficacy and safety of nintedanib in people with a rare disease called systemic sclerosis (SSc) who also developed interstitial lung disease (SSc-ILD) (NCT02597933).¹ In total, 520 people are expected to be enrolled in clinical trial centres worldwide.

Systemic sclerosis, also known as scleroderma, is a rare disease characterised by the thickening and scarring of connective tissue of multiple organs in the body.² The scarring can also affect the lungs and when this occurs the condition is called SSc-ILD.² The presence of ILD with SSc often indicates a poor prognosis and higher risk of death.²

“People affected by SSc-ILD are often young, between 25 and 55 years old,³ and are faced with considerable disability related to the systemic nature of scleroderma. They often have significant shortness of breath and cough from lung disease and severe pain and contractures as a consequence of their skin involvement. This occurs during years when they are deeply engaged in building careers and caring for family,” said Kristin Highland, M.D. of the Cleveland Clinic Foundation. “There are no approved treatments for SSc-ILD, and few drugs have been assessed in clinical trials for this disease.⁴ The SENSCIS^™ trial will help to further inform the medical community about SSc-ILD and whether nintedanib could be an effective therapy for people with this condition.”

It is estimated that SSc-ILD affects up to 86,000 people in the U.S. and 200,000 people in Europe, making it an orphan, or rare disease.^5,6,7 Worldwide, it is estimated that approximately two million people have SSc,⁸ and up to 90 percent may develop some degree of ILD.⁵

“The patient community has been waiting for approved treatments for systemic sclerosis patients who have developed the critical complication of interstitial lung disease, and it welcomes Boehringer Ingelheim’s research conducted in this disease area,” said Ann Kennedy, Federation of European Scleroderma Associations (FESCA aisbl).

“Nintedanib, which is marketed as OFEV^®, is approved for a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function. Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease,⁵ we are evaluating whether nintedanib can have a beneficial impact on lung fibrosis associated with SSc,” said Dr William Mezzanotte, Therapeutic Area Head, Respiratory Medicine at Boehringer Ingelheim. “The SENSCIS^™ study is another milestone in our ongoing commitment to furthering science that addresses the unmet needs of people affected by rare diseases and serious respiratory conditions, including fibrotic lung diseases.”

Additional information

About SENSCIS^™​
SENSCIS^™ is a randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of nintedanib 150 mg twice daily over 52 weeks up to a maximum of 100 weeks in people with SSc-ILD. The primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of disease progression. Key secondary endpoints include the absolute change from baseline in the modified Rodnan Skin Score (mRSS), which is an evaluation of people’s skin thickness, and the absolute change from baseline in the Saint George’s Respiratory Questionnaire (SGRQ) total score, which measures the health-related quality of life of people with lung diseases to assess the impact of treatment.

About SSc and SSc-ILD
Systemic sclerosis (SSc) is a rare and serious disease characterised by thickening and scarring of connective tissue of multiple organs in the body.² It is difficult to diagnose because a lot of organ systems are involved and its symptoms are similar to other autoimmune diseases.³ The disease impacts four times as many women as men, and the onset of the disease typically occurs at a young age – between 25 and 55 years.³

Nearly all people with SSc have hardening and thickening of patches of skin.² The disease also can cause scarring in the lungs, heart, or kidneys, which can become life-threatening.²

When this scarring affects the lungs it is called SSc-ILD2 and can make it difficult to breathe and perform daily activities.³ Lung involvement like ILD is the leading cause of death among people with SSc.²

For more information, please visit clinicaltrials.gov/ct2/show/NCT02597933.

About OFEV^® (nintedanib)
OFEV^® is a small molecule tyrosine kinase inhibitor developed by Boehringer Ingelheim for IPF.⁹ OFEV^®, one capsule twice a day, slows disease progression by reducing the annual rate of decline in lung function by 50% in a broad range of IPF patient types. ^{10,11,12,13,14,15} This includes patients with early disease (FVC >90% pred)¹² limited radiographic fibrosis (no honeycombing) on high resolution computed tomography (HRCT)13 and those with emphysema.¹⁴ Side effects with OFEV^® can be effectively managed in most patients.¹⁰

OFEV^® targets growth factor receptors, which have been shown to be involved in the mechanisms by which pulmonary fibrosis occurs. Most importantly OFEV^® inhibits platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR).^10,16,17 It is believed that OFEV^® reduces disease progression in IPF and slows the decline in lung function by blocking the signalling pathways that are involved in fibrotic processes.^10,17,18

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

For more information please visit www.boehringer-ingelheim.com

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