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news.Roche has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to begin a multicenter, Phase II clinical trial of Erivedge (vismodegib) in patients with idiopathic pulmonary fibrosis (IPF).
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Roche and Genentech, a member of the Roche Group, develop and commercialize Erivedge under a deal with Curis, a US-based oncology-focused biotechnology firm.
Curis president and chief executive officer Ali Fattaey said the company is happy with this important decision by Roche to expand the development of Erivedge outside of oncology for the first time, especially in IPF where Hedgehog pathway activation is associated with the disease.
"IPF represents a serious unmet medical need and patients suffering from this disease are in need of improved treatment options," Fattaey said.
"The IND filing is currently under review by the FDA and we look forward to providing additional details on the study as they become available."
Roche submitted the IND for a Phase II randomized, multi-center, double-blind, placebo-controlled, parallel-group trial to assess the safety and efficacy of Erivedge in patients with IPF.
In the trial, Erivedge will be administered orally at a dose of 150mg daily for duration of 52 weeks.
The trial’s primary endpoint is mean change in forced vital capacity (FVC) percent predicted from baseline to week 52 in patients with IPF.