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

• First person enrolled in the SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS) study investigating nintedanib in people with systemic sclerosis who also develop interstitial lung disease (SSc-ILD)
• Phase III trial is now open for recruitment
• After demonstrating that nintedanib slows disease progression in idiopathic pulmonary fibrosis, Boehringer Ingelheim is expanding its research with nintedanib into other serious fibrotic lung conditions that arise in association with rare diseases like systemic sclerosis

INGELHEIM, Germany--(BUSINESS WIRE)--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.”

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