January 17, 2014 Reprinted from company statement by Boehringer Ingelheim
Following an assessment of the blinded Phase 3 trial data from HCVerso® 1 and 2 for the combination of deleobuvir, faldaprevir and ribavirin, Boehringer Ingelheim has decided to halt further development of deleobuvir-containing hepatitis C (HCV) regimens.
The combination showed a higher rate of premature discontinuations suggesting a lower efficacy rate compared to other interferon-free therapies in development. Boehringer Ingelheim has therefore concluded that the expected therapeutic value of the deleobuvir-containing regimen would not justify further development.
Faldaprevir, Boehringer Ingelheim's investigational HCV protease inhibitor, has shown promising results in combination with pegylated interferon and ribavirin in the STARTVerso™ trials. Ongoing regulatory reviews of faldaprevir are not affected by the decision on the deleobuvir-containing regimens. In the US, Boehringer Ingelheim will move forward with the submission process for faldaprevir.
Boehringer Ingelheim is committed to developing new treatments that provide high therapeutic value in areas of unresolved medical need. The company is focusing its efforts on numerous promising development projects in areas, such as immunology, cardiovascular, respiratory, metabolic diseases, diseases of the central nervous system and oncology.
Published Aug 2013 in the New England Journal of Medicine: Faldaprevir and Deleobuvir for HCV Genotype 1 Infection
Hepatitis C: Boehringer Ingelheim’s faldaprevir granted accelerated assessment from European Medicines Agency