NPS Pharmaceuticals Announces Completion of Top Study Dosing, Launch of Crohn's Trial
Tuesday October 7, 5:00 pm ET
# SALT LAKE CITY, Oct. 7 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. (Nasdaq: NPSP - News) today reported clinical progress with two of the company's late-stage drug candidates, PREOS® and teduglutide (ALX-0600).
TOP Study Dosing Completed
NPS announced that it has completed dosing of all patients that participated in its pivotal, 18-month Phase III trial for PREOS, which is recombinantly produced, full-length human parathyroid hormone, (PTH). The trial, known as the TOP (Treatment of Osteoporosis with PTH) study, was designed to test the ability of PREOS to reduce fracture rates in postmenopausal women with osteoporosis. NPS expects to report results of the TOP study late in the first quarter of 2004, following compilation and analysis of data from this comprehensive trial. Approximately 165 clinical centers in North America, Latin America, and Europe participated in the study in which nearly 2700 women were enrolled.
NPS noted that patients have the option of continuing in the Open Label Extension Study (OLES) arm of the TOP study, which allows women to receive active drug therapy for a total of up to 24 months of treatment. To date, more than 75% of eligible patients have chosen to enter OLES.
Crohn's Disease Study Underway
The company also announced that a proof-of-concept study is now underway to evaluate the possible utility of teduglutide in the treatment of patients with Crohn's disease. Teduglutide is a derivative of a naturally occurring protein involved in the regulation of various processes of the gastrointestinal tract. In previous human tests, teduglutide produced a significant growth effect on cells that line the intestines. Researchers will now test the compound to see if this result can be duplicated in Crohn's patients, and if there is an indication that this may be beneficial in increasing the health of the intestinal lining and reducing symptoms of the disease.
The dose-ranging, multi-center study will enroll approximately 100 patients with active Crohn's disease divided into four groups, with three groups receiving various doses of teduglutide, and the fourth group receiving a placebo. All doses of the compound and the placebo will be administered by daily subcutaneous injections for eight weeks. The primary endpoint of the study will be a reduction in the Crohn's Disease Activity Index (CDAI), which is a score based on an assessment of factors related to symptoms of the disease. Lower CDAI scores following treatment with teduglutide would indicate a possible therapeutic effect. NPS anticipates that it will report results of the study by the end of 2004.
"We're pleased with the strides that we continue to make in the development of these potential therapies," said Dr. Hunter Jackson, Chairman and CEO of NPS. "PREOS is advancing toward its application to the FDA for marketing approval, and the initiation of the Crohn's study with teduglutide represents progress with another important drug candidate in the company's pipeline. I extend my appreciation and congratulations to our development teams for their effective work in advancing these programs." |
