Alnara to announce Phase 3 study results of liprotamase for treating cystic fibrosis at the 23rd NACFC

Oct 5 2009

Alnara Pharmaceuticals, Inc., a pharmaceutical company developing novel, non-systemic orally-delivered protein therapeutics for the treatment of metabolic diseases, announced today that results from a landmark, international Phase 3 study of the long-term safety and nutritional benefits of liprotamase for the treatment of pancreatic insufficiency in patients with cystic fibrosis (CF) will be presented at the 23^rd Annual North American Cystic Fibrosis Conference (NACFC) being held October 15-17, 2009 in Minneapolis, Minnesota. Liprotamase is being developed in collaboration with the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), a nonprofit affiliate of the Cystic Fibrosis Foundation. The 12-month study is the largest and longest prospective nutritional and safety study ever completed for a pancreatic enzyme replacement therapy (PERT).

Liprotamase is a novel, oral, non-porcine PERT designed to treat maldigestion, malabsorption and malnutrition as a result of exocrine pancreatic insufficiency associated with CF, chronic pancreatitis (CP), pancreatic cancer, pancreatectomy and other pancreatic conditions. Findings from the open-label, Phase 3 long-term safety and nutritional study in patients with CF will be presented by Drucy Borowitz, M.D., Professor of Clinical Pediatrics, State University of New York at Buffalo, on Saturday, October 17, 2009 at 2:55 p.m. CDT.

This trial completes the liprotamase new drug application (NDA) clinical development program which has included approximately 600 subjects in various efficacy and safety studies. In this study, 145 CF patients treated with liprotamase were evaluated over a 12-month period for both safety and nutritional measures that included height, weight and Body Mass Index (BMI), which are important measures of PERT performance.

“This 12-month safety and nutritional study is truly a landmark study in the development of pancreatic enzyme therapies, and we believe the findings presented at the NACFC will reinforce the significant potential for liprotamase to advance the care of people living with CF,” stated Alexey Margolin, Ph.D., president and chief executive officer of Alnara. “Of particular interest to the clinical community will be the results noted for specific nutritional measures such as height, weight and body mass index which are the key measures of success for PERT. We look forward to sharing these data with the CF community.”

Liprotamase has successfully completed two well-controlled, clinical efficacy trials and an additional year long-term safety and nutritional study in CF, representing the largest CF population studied in prospective clinical trials for a PERT. Liprotamase met the primary endpoint in both pivotal efficacy trials and demonstrated statistically (p≤0.001) and clinically significant improvement in fat and protein absorption. Results from these previously reported studies show liprotamase was well tolerated and in addition, improved other important clinical measures such as stool weight and frequency.

The new data on liprotamase from the landmark, long-term, international Phase 3 safety and nutritional study in patients with CF, which will be announced at the NACFC, is one of two long-term studies completed. The long-term safety and nutritional benefits of liprotamase was also evaluated in a second Phase 3 study in patients with chronic pancreatitis or pancreatectomy.