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Ingelheim, Germany, 16 November 2010 – New data presented at the 16th International Colloquium on Lung and Airway Fibrosis (ICLAF) show that Boehringer Ingelheim’s investigational compound BIBF1120, a triple kinase inhibitor, may provide significant clinical benefit in patients with idiopathic pulmonary fibrosis (IPF).1
IPF is a progressive and severely debilitating lung disease2, for which there are no approved treatments in the USA or Europe and there is an unmet clinical need for effective licensed agents.
Results from the Phase II TOMORROW study, presented by Professor Luca Richeldi from the Center for Rare Lung Diseases at the University of Modena and Reggio Emilia, Policlinico Hospital, Modena, Italy, show that 12 months’ treatment with BIBF1120 resulted in a clinically important reduction in the rate of decline in lung function in patients with IPF.
The trial investigated the safety and efficacy of four doses of BIBF 1120 and results demonstrated that the annual rates of FVC decline (primary endpoint), were:
0.19 L (in the placebo arm); 0.17 L (BIBF 1120 50 mg once daily); 0.21 L (BIBF 1120 50 mg twice daily); 0.16 L (BIBF 1120 100 mg twice daily); and 0.06 L (BIBF 1120 150 mg twice daily) with a p-value of 0.0136; closed-testing multiplicity corrected: p=0.0639.
The 150 mg twice daily dose of BIBF1120 provided a 68% reduction in the rate of decline compared with placebo.
Secondary endpoints supported the efficacy of BIBF1120. The percentage of the predicted value of FVC was better preserved in the 100 mg and 150 mg twice daily BIBF1120 groups compared with placebo. Only 2 (2.3%) patients in the 150 mg twice daily BIBF1120 group suffered from an acute exacerbation of the disease during the 12-month study period, compared with 12 (13.8%) patients in the placebo group (p <0.05). In addition, patients taking 150 mg twice daily BIBF1120 reported less deterioration in quality of life according to the St George’s Respiratory Questionnaire (SGRQ) compared with patients taking placebo (p <0.01).
“These results are very encouraging. Using an innovative approach to treating idiopathic pulmonary fibrosis, an effect has been shown on the primary and several other clinically relevant study endpoints. Taken together, these data provide a solid and promising platform for the development of a Phase III program.” said Professor Luca Richeldi from the Center for Rare Lung Diseases at the University of Modena and Reggio Emilia, Policlinico Hospital, Modena, Italy.
The total number of adverse events reported was similar in the BIBF1120 and placebo groups. The most frequently reported adverse events in patients taking BIBF1120 were diarrhoea, nausea, vomiting, abdominal pain and reversible increases of liver transaminases. Discontinuations due to adverse events were more frequent in the BIBF1120 150 mg twice daily group (31.8%), but less frequent in the BIBF1120 100 mg twice daily group (15.1%), than in the placebo group (24.7%).
About the TOMORROW Study
The TOMORROW (TO IMPROVE PULMONARY FIBROSIS WITH BIBF1120) study was a 12-month, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of oral BIBF1120 on decline in forced vital capacity (FVC) in patients diagnosed with IPF using current ATS/ERS criteria. A total of 432 patients with IPF from 86 sites in 25 countries were randomized to receive 1 of 4 doses of BIBF1120 (50 mg once daily, 50 mg twice daily, 100 mg twice daily, or 150 mg twice daily) or placebo for 12 months.
BIBF1120 is a small molecule triple kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR). These receptors have been shown to be involved in fibrosis of the lungs.3 By blocking the signalling pathways that lie downstream from these receptors, it is hypothesized that BIBF1120 inhibits one of the pathogenic processes in IPF. BIBF1120 is not licensed for the treatment of any condition in any country.
Apart from IPF, Boehringer Ingelheim’s investigates BIBF 1120 also in Phase III clinical studies for the treatment of cancer patients in two different cancer types, advanced NSCLC and ovarian cancer.
IPF is characterized by fibrosis (stiffening) of the tissue between the alveoli in the lungs, which causes coughing and breathing difficulties and limits physical activity.4,5 Unpredictable acute exacerbations of the disease occur in some patients and may be fatal.6 The mean age at diagnosis is 66 years.2 IPF has a survival rate similar to many cancers, with a mean survival time following diagnosis of 3 to 5 years.2 At present there are no licensed pharmacologic treatments for IPF in the USA or Europe.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed for 125 Years to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.
1. Richeldi L et al. Oral presentation at ICLAF 2010, Perth, Australia. 31.10.2010.
2. ATS & ERS. Am J Respir Crit Care Med 2000; 161:646-664.
3. Allen JT, Spiteri MA. Respir Res 2002; 3:13.
4. Selman M et al. Ann Intern Med 2001; 134:136-151.
5. De Vries J et al. Eur Respir J 2001; 17:954-961.
6. Tiitto L et al. Thorax 2006; 61:1091-1095.