Altus's Phase III Efficacy Trial of Trizytek Meets Primary Endpoint
Posted on: Wednesday, 13 August 2008, 12:00 CDT
Altus Pharmaceuticals has announced that its Phase III efficacy trial of Trizytek in patients with cystic fibrosis met its primary endpoint of improvement in fat absorption.
The company released top-line results from its 163 patient, double-blind, placebo-controlled trial of Trizytek, an enzyme replacement therapy for patients with pancreatic insufficiency.
Trizytek is a stable and pure combination of three active enzymes in a fixed-ratio that is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals, the company said.
The trial met its primary efficacy endpoint with statistical significance. In cystic fibrosis patients with exocrine pancreatic insufficiency, Trizytek demonstrated a statistically significant improvement of fat absorption over placebo through the measurement of the coefficient of fat absorption (CFA). The primary efficacy analysis was an intent to treat analysis in the sub-group of patients with severe malabsorption (baseline CFA below 40). In addition, data were analyzed for the overall group, which included all patients with baseline CFA below 80.
Georges Gemayel, president and CEO of Altus Pharmaceuticals, said: "We are pleased to have met our primary endpoint for improvement in CFA with Trizytek and this achievement is a major milestone for our company. The outcomes were driven by the strong positive data from the 26 centers in the US, where we will be initially seeking approval upon completion of our long-term safety studies."
Source: Datamonitor
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