New Therapy for Cystic Fibrosis Patients with Pancreatic Insufficiency Enters Phase 3 Clinical Trials
May 31, 2007
Altus Pharmaceuticals, headquartered in Cambridge, Mass., announced the start of their Phase 3 clinical trials to evaluate the safety and efficacy of ALTU-135, a new oral pancreatic enzyme replacement therapy. Pancreatic insufficiency is found in approximately 90 percent of individuals with cystic fibrosis and is treated through the administration of enzymes that help patients to enhance digestion, improve growth, reduce gastrointestinal problems, and contribute to general nutritional health.
Enzyme products for pancreatic insufficiency in use today are porcine-derived and require patients to take multiple capsules—sometimes 4 or 5—with every meal or snack. ALTU-135, in contrast, is microbially derived and requires taking only one smaller capsule with every meal or snack.
In a previous Phase 2 study, ALTU-135 was found to be 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. The Phase 3 trial, named DIGEST, will recruit approximately 300 patients in nearly 50 sites in the U.S. and abroad. Altus expects the trial to be completed in 2009 and, if the results are positive, will file for regulatory clearance in the U.S. during the first half of that year.
To participate or find out more about the trial please visit www.altus.com/digesttrials.cfm.