Altus(R) Pharmaceuticals Inc. presented results from its Phase II clinical trial of ALTU-135 (TheraCLEC(TM)) in cystic fibrosis (CF) patients with malabsorption due to pancreatic insufficiency at the North American Cystic Fibrosis Conference in Baltimore, MD. In the study, when delivered at a fixed dose, ALTU-135 was well-tolerated and achieved statistically significant improvements in the absorption of fat and protein as well as an overall improvement in the absorption of carbohydrates, all of which are essential for proper nutrition and growth. The Phase II study enrolled 125 patients who were treated at 26 CF centers in the U.S., and the Company believes that it represents the largest prospective, randomized, double blind, and dose-ranging trial conducted to evaluate the safety and efficacy of enzyme replacement therapy in the treatment of CF patients with pancreatic insufficiency.
