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).
IPF is a progressive and severely debilitating lung disease, 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 two (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%).