The Phase II TOMORROW study was a 12-month, randomised, double-blind, placebo-controlled trial, aimed to evaluate the impact of oral BIBF1120 on decline in forced vital capacity (FVC) in patients with IPF, involving 432 patients from 86 sites in 25 countries, receiving one of four doses.
The study investigating the safety and efficacy of four doses of BIBF1120- 50 mg once daily, 50 mg twice daily, 100 mg twice daily, 150 mg twice daily, showed reduction in the rate of lung function decline in the IPF patients.
The Center for Rare Lung Diseases at the University of Modena and Reggio Emilia, Policlinico Hospital, Modena, Italy professor Luca Richeldi said the trial results showed an effect 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," Richeldi said.
The number of adverse events were similar in the BIBF1120 and placebo groups while the most frequently reported adverse events in patients taking BIBF1120 had been abdominal pain, diarrhoea, nausea, vomiting and reversible increase of liver transaminases.
Discontinuations due to adverse events were less frequent in the BIBF1120 100 mg twice daily group (15.1%) but more frequent in the BIBF1120 150 mg twice daily group (31.8%), compared to the placebo group (24.7%).