Phase III study showed ninted

• Results of pivotal Phase III SENSCIS^®      trial published today in the New England Journal of Medicine (NEJM)      and presented at the American Thoracic Society Conference in Dallas, USA

• Interstitial lung disease (ILD) is a key driver      of mortality in people living with systemic sclerosis (SSc) – also known      as scleroderma – and the absence of approved treatment options constitutes      a high unmet need^2,3

• FDA grants priority review to application for      regulatory approval for nintedanib in patients with systemic sclerosis      associated interstitial lung disease (SSc-ILD)

INGELHEIM, Germany -- (BUSINESS WIRE) --

Boehringer Ingelheim today announced that the SENSCIS^® trial met its primary endpoint: reduction in the annual rate of decline in forced vital capacity (FVC^a) in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). Results show that nintedanib slows the loss of pulmonary function in patients with SSc-ILD compared to placebo. Patients taking nintedanib showed a 44% reduction in the rate of decline of their lung function, measured in FVC assessed over 52 weeks¹. These new data were today published in the New England Journal of Medicine (NEJM) and presented to the medical community at the American Thoracic Society (ATS) International Conference, in Dallas, USA.

SENSCIS^® is the largest randomised controlled trial to be conducted in patients with SSc-ILD, a disease for which there are currently no approved treatments.^1,3,4 Results also showed that nintedanib had a safety and tolerability profile similar to that observed in patients with idiopathic pulmonary fibrosis (IPF)¹, with the most common adverse event being diarrhoea. Nintedanib is already approved in more than 70 countries for the treatment of IPF. These trial results formed the basis of the application for regulatory approval of nintedanib in SSc-ILD that was filed with the FDA and EMA by Boehringer Ingelheim in the first quarter of 2019. The FDA recently granted priority review to the supplemental application for nintedanib in SSc-ILD. The regulatory submissions are part of the company’s ongoing commitment to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need.

Systemic sclerosis, also known as scleroderma, is a rare incurable autoimmune disease affecting connective tissue.^3,4,5 It can cause scarring (fibrosis) of the skin as well as major organs such as the heart, lungs, digestive tract and kidneys and can have life-threatening complications.^2,3 Approximately 25 percent of patients develop significant pulmonary involvement within three years of diagnosis.⁶ When SSc affects the lungs it can cause interstitial lung disease (ILD), known as SSc-ILD.^2,3 It is a key driver of mortality among people with SSc, accounting for approximately one third of deaths.^7,8

SENSCIS^®, a Phase III double-blind, randomised, placebo-controlled trial, involved 576 patients across more than 32 countries. The primary endpoint was the annual rate of decline in FVC in mL over 52 weeks.¹ At the end of the 52-week trial, patients receiving nintedanib had an adjusted annual rate of decline in FVC (mL/year) of -52.4 with nintedanib, versus -93.3 with placebo (absolute difference 41.0mL/year [95% CI 2.9, 79.0]; p=0.04). This corresponds to a relative difference of 44% reduction in lung function decline¹, similar to the results from the Phase III INPULSIS^® trials in IPF.¹² FVC is an established measurement of lung function. As ILD progresses, lung function gradually and irreversibly deteriorates.⁹

“The SENSCIS results provide positive news for people living with SSc-ILD and their physicians because currently there are no approved treatments” explained Professor Oliver Distler, Professor of Rheumatology, University Hospital Zurich and lead investigator of the trial. “A 44% reduction in lung function decline indicates a significant slowdown in disease progression. Nintedanib could make a considerable difference to the lives of people with this rare and often life-threatening disease.”

“We are pleased to be able to share the positive results of the pivotal SENSCIS trial that are very consistent with the database from IPF and formed the basis of the recent submissions Boehringer Ingelheim made to the FDA and EMA for regulatory approval of nintedanib in February and March 2019”, said Dr. Susanne Stowasser, Associate Head of Medicine, Respiratory at Boehringer Ingelheim. “Fibrotic lung diseases including SSc-ILD continue to have a devastating impact on people’s lives and our focus remains on making treatments available to improve the lives of patients in areas of high unmet need.”

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