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New Study Published in New England Journal of Medicine Shows Investigational BIBF 1120 Demonstrated Positive Trend in Reducing Lung Function Loss in Idiopathic Pulmonary Fibrosis
Date:9/21/2011

RIDGEFIELD, CT, Sept. 21, 2011 /PRNewswire/ -- Boehringer Ingelheim's investigational tyrosine kinase inhibitor (TKI) BIBF 1120 demonstrated a positive trend in reducing lung function decline in patients with idiopathic pulmonary fibrosis (IPF), according to phase II clinical trial results published today online in the New England Journal of Medicine (NEJM). IPF is a progressive and severely debilitating lung disease with a high mortality rate, for which there are no approved treatments in the United States.

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In the study, known as TOMORROW (To Improve Pulmonary Fibrosis with BIBF 1120), patients treated with 150 mg of BIBF 1120 twice daily demonstrated a 68 percent reduction in the rate of forced vital capacity (FVC) decline compared to placebo. FVC is the volume of air that is expelled into a spirometer following maximum inhalation. FVC, which is a test that measures lung function, is a part of the examinations conducted in IPF patients and is scientifically accepted for assessment of IPF treatment effects. Patients treated with 150 mg of BIBF 1120 twice daily also had a lower incidence of acute exacerbations, defined as sudden deterioration of clinical status, compared with placebo. Acute exacerbations are associated with rapid disease progression, severe abrupt decline in FVC and high mortality.

In addition, treatment with 150 mg of BIBF 1120 twice daily resulted in a small decrease in impairment of quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ). SGRQ scores measure the impact of quality of life, with higher scores – as well as increasing scores – signaling greater impairment. In contrast, increased impairment was reported among patients receiving placebo.

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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