Curis, an oncology-focused biotechnology company developing novel drug candidates for cancer treatment, today announced that Roche filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a multicenter, Phase 2 clinical study of Erivedge (vismodegib) in patients who suffer from the debilitating lung disease idiopathic pulmonary fibrosis (IPF).
In the company’s announcement, Curis explained that Roche submitted the IND for a Phase 2 randomized, multi-center, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of Erivedge in patients with IPF. The companies hope the drug will result in a mean change in forced vital capacity (FVC) percent — a measure of pulmonary function — predicted from baseline up to a year in patients with IPF. Once approved by the FDA, the clinical trial is expected to enroll 130 patients and will begin in late 2014.
This IND filing is a step toward another big win for Curis’ development and commercialization collaboration with Roche and Genentech. It will be the first time the drug could be used for a noncancerous disease.
"We are pleased 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," Ali Fattaey, Ph.D., President and CEO of Curis said. "IPF represents a serious unmet medical need and patients suffering from this disease are in need of improved treatment options. 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."
Erivedge was developed by Roche through a collaboration agreement with Curis. Currently, the Erivedge capsule is “the first and only oral medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with metastatic basal cell carcinoma (BCC), or with locally advanced BCC that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation,” according to Genentech.
In July 2013, the EU granted a conditional approval to Erivedge for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. This made Erivedge the first licensed treatment in Europe for patients with advanced BCC, a rare, debilitating form of skin cancer.