Altus starts Ph III trial of ALTU-135
USA-based drugmaker Altus Pharmaceuticals says it has initiated a Phase III trial of ALTU-135, its developmental treatment for cystic fibrosis patients suffering from pancreatic insufficiency. The drug in an oral enzyme replacement therapy that is designed to improve the absorption of fat, protein and carbohydrate.
The DIGEST program, which will consist of two Phase III trials, is designed to assess ALTU-135's efficacy and safety, and will seek to recruit more than 300 patients at 50 research centers worldwide. The firm added that it has begun a long-term, open-label safety study that will evaluate the drug over a one-year period. The assessment is expected to produce final data in 2009.
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