Altus Pharmaceuticals trial finds TheraClec helps cystic fibrosis patients

New York, Oct. 24 - Altus Pharmaceuticals Inc. said that a phase II clinical trial of ALTU-135, known as TheraClec, produced significant improvements in the absorption of fat and protein and an overall improvement in the absorption of carbohydrates among cystic fibrosis patients with pancreatic insufficiency.

The study involved 125 patients at 26 centers in the United States.

"We are encouraged by these Phase II results," said Alan Kimura, vice president, clinical development and medical affairs at Altus Pharmaceuticals, in a news release.

"As the Food and Drug Administration noted in April 2004, there is a need for efficacious pancreatic enzyme replacement therapies with consistent quality, potency, and stability. We are optimistic that ALTU-135 will meet these goals while providing a more convenient option for patients."

Altus said it has begun working with the FDA to finalize design of a phase III clinical trial.

ALTU-135 is an orally-delivered, microbially-derived enzyme replacement therapy that uses Altus' protein crystallization and cross-linking technology. It consists of three enzymes, lipase, protease and amylase that are delivered in a consistent ratio and is designed to improve fat, protein, and carbohydrate absorption in pancreatic insufficient individuals.

Altus is a Cambridge, Mass., company focused on developing and commercializing protein therapeutics for patients with chronic gastrointestinal and metabolic diseases.

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