NPS to advance clinical development of teduglutide as treatment for Crohn's disease

By Ted A. Knutson

Washington, Feb. 27 - NPS Pharmaceuticals, Inc. said Monday the company plans to advance the clinical development of its experimental drug teduglutide based upon results achieved in a phase 2a proof-of-concept study of 100 patients with moderate to severe Crohn's disease.

Overall, the study results showed a positive and consistent trend toward efficacy and a dose response favoring the highest dose group: 36.8% of patients receiving the highest dose of teduglutide reached clinical remission (Crohn's disease activity index score of less than 150 points) at week two versus 16.7% of the placebo group, while 55.6% of patients 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 adverse events related to the drug. The most common treatment-related adverse event in the trial was redness at the injection site. Study investigators plan to submit the trial results for presentation at a future medical meeting.

Remission rates of this magnitude at two weeks and eight weeks are unusual in clinical trials and suggest that teduglutide may play an important role in the management of this difficult-to-treat disease, a researcher for the study noted.

Although the study was not powered to demonstrate statistical significance and the primary endpoint - the percentage of patients who achieved remission or at least a 100-point reduction from their baseline CDAI score at week eight - was not met due to the relatively small number of study subjects and a high placebo response, the company believes the high clinical remission rates seen in patients receiving the highest dose of teduglutide support further dose-ranging efficacy studies of teduglutide in patients with Crohn's disease.

"We are pleased with the results from this trial and the suggestion that some patients demonstrated remission as early as two weeks into the study. The high placebo response seen in this trial is not unusual in Crohn's disease. We plan to conduct additional studies to confirm the efficacy response observed in this trial and look forward to advancing this novel compound into later-stage development this year as a promising treatment alternative in Crohn's disease," said Hunter Jackson, Ph.D., NPS chairman and chief executive officer, in a press release.

Teduglutide is a proprietary analog of glucagon-like peptide 2, a naturally occurring hormone that regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract. A previous phase 2 clinical study in patients with Short Bowel Syndrome showed that daily subcutaneous injections of teduglutide resulted in significant growth of the intestinal lining and improved dietary absorption of nutrients and fluids.

NPS is testing teduglutide in a pivotal phase 3 study as a treatment for Short Bowel Syndrome.

Salt Lake City-based NPS discovers, develops and commercializes small molecules and recombinant proteins as drugs, primarily for the treatment of metabolic, bone and mineral, and central nervous system disorders.

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