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Study Shows Novel Therapy May Produce Early Remission in Crohn's Patients

LOS ANGELES, C.A. -- May 30, 2006 -- Northwestern University's Feinberg School of Medicine today announced that Alan Buchman, MD, Associate Professor and Director of the school's Inflammatory Bowel Disease Center, discussed results of a double-blind, placebo-controlled, Phase IIa proof of concept study of teduglutide, an investigational medication.

Top line results were reviewed today at a press conference at the annual Digestive Disease Week 2006 (DDW®) Meeting taking place May 20 to 25 in Los Angeles. Additional teduglutide data will be presented at a Late-Breaking Abstract Session Tuesday, May 23, 2006 from 2:45 p.m. to 3:00 p.m. PST in Room 501 A/B/C at the Los Angeles Convention Center.

Teduglutide represents the first of a novel class of therapy under study for Crohn's disease and is a proprietary analog of the naturally occurring human peptide glucagon-like peptide 2 (GLP-2). GLP-2 regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract and is currently under clinical development by NPS Pharmaceuticals, Inc., the study sponsor.

"There is an urgent need for new treatment options for patients with moderate-to-severe Crohn's disease who are unable to alleviate its painful and life-altering symptoms," Dr. Buchman said. "Achieving remission this early could deliver significant quality of life benefits for these patients and suggest that teduglutide should be studied in additional clinical trials at higher doses to determine its role in the management of this difficult to treat disease."

The four-arm, eight-week Phase IIa study in 100 participants with moderate-to-severe Crohn's disease was designed to evaluate the drug's safety and potential efficacy. Researchers compared three doses of teduglutide delivered by daily subcutaneous injection to a placebo. The primary endpoint of the study was remission or at least a 100-point reduction from the baseline Crohn's disease activity index (CDAI) score at week 8.

While the study did not demonstrate statistical significance in its primary endpoint, the results showed a positive and consistent trend toward efficacy and a dose response favoring the highest dose group: 36.8% of participants (receiving the highest dose of teduglutide reached clinical remission and CDAI score of less than 150 points) at week two versus 16.7% of the placebo group, while 55.6% of participants in the highest dose group reached clinical remission by week eight compared to 33.3% of the placebo group. Teduglutide was well tolerated with no serious drug-related adverse events. Adverse events observed in the study included abdominal pain and redness at the injection site.

About Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disease (IBD) that affects approximately one million patients in the United States and Europe. Symptoms include abdominal pain, diarrhea, rectal bleeding and weight loss. Presently, Crohn's disease is incurable, although some patients experience long periods of remission.


SOURCE: Northwestern University

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