Roche applies for IND for idiopathic pulmonary fibrosis treatment
- Roche has applied to start phase II trials of Erivedge (vismodegib) for treatment of idiopathic pulmonary fibrosis (IPF).
- The trial will be a randomized, multi-center, double-blind, placebo-controlled, parallel-group trial to assess safety and efficacy in patients with IPF.
- Roche and Genentech (which is a member of the Roche Group) are developing and commercializing Erivedge under a deal with the biotechnology firm, Curis.
Erivedge was initially approved for the treatment of metastatic basal cell carcinoma (BCC) in January 2012. The phase II data was so compelling—the drug eliminated cancer in 43% of patients with locally advanced cancer and 30% of patients with metastatic cancer---that FDA approved the drug based on phase II data.
Roche’s foray into clinical studies of Erivedge for treatment of IPF is the company’s first effort to apply this therapy outside of oncology. The common denominator between BCC and IPF is a signal known as Hedgehog. Pathway activation of Hedgehog is implicated in both diseases. The first 52-week trial will focus on mean change in forced vital capacity as a primary endpoint.
- Pharmaceutical Business Review Roche files IND application to begin phase II trial of IPF drug Erivedge
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