Altus Pharmaceuticals Achieves Primary Endpoint in Phase 3 Efficacy Trial of Trizytek for Cystic Fibrosis Patients

13-Aug-2008

Altus Pharmaceuticals Inc. announced that its Phase 3 efficacy trial of Trizytek(TM) (porcine-free enzymes) in patients with cystic fibrosis (CF) successfully 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.

According to the company, Altus' Trizytek Phase 3 clinical program is the largest ever conducted to evaluate the efficacy and safety of pancreatic enzyme replacement therapy in cystic fibrosis patients. Detailed trial results will be presented at the North American Cystic Fibrosis Conference in October 2008. 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 (ITT) 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.

Patients treated with Trizytek had a statistically significant improvement in CFA compared to placebo. In the Trizytek CFA below 40 group, there was an improvement in the mean CFA of 20.2 (80% change from baseline). In the placebo CFA below 40 group, there was an increase in mean CFA of 5.1 (24% change from baseline). The mean difference between groups for the change in CFA was 15.1 (p=0.001).

https://www.bionity.com/en/news/85672/altus-pharmaceuticals-achieves-primary-endpoint-in-phase-3-efficacy-trial-of-trizytek-for-cystic-fibrosis-patients.html