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Novel Compound Targets Mucosal Healing in Crohn's
      05/29/06 02:19 PM
HeatherAdministrator

Reged: 12/09/02
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LOS ANGELES, May 23 — A novel treatment that targets mucosal protection and healing rather than inflammation led to fast and significant efficacy in patients with moderate to severe Crohn's disease, researchers said here.


At the highest tested dose, teduglutide, an analog of the naturally occurring human peptide glucagon like peptide-2 (GLP-2), elicited a response at two weeks in more than 50% of patients, reported Alan L. Buchman, M.D., of Northwestern University in Chicago at Digestive Disease Week sessions here. The agent was self injected subcutaneously daily.


At eight weeks more than 60% of patients randomized to 0.20 mg/kg daily had more than a 100-point drop in the Crohn's Disease Activity Index (CDAI). The response rate was similar in the placebo group (57%). Moreover, the clinical remission rate, defined as a CDAI of less than 150 points, was more than 50% for patients in the 0.20 mg/kg group.


The dose-ranging, proof of concept trial tested three dose regimens: 0.05 mg/kg/day; 0.10 mg/kg/day; and the 0.20 mg/kg/day dose.


"We still don't know maximum dose or maximum efficacy," said Dr. Buchman.


"We sent the bar very high in this trial," he said. "Our endpoint was complete remission by primary healing of the mucosa. Our secondary endpoint was reduction of inflammation." Inflammation was measured by surrogate markers, but Dr. Buchman did not report those data.


"Inflammatory bowel disease starts in the gut, so if you can heal the gut, you can probably heal the rest of the body," Dr. Buchman said, suggesting why teduglutide demonstrated such surprising efficacy.


Maria Abreu, M.D., of Mount Sinai in New York, said she, too was impressed with the results. The typical response with biologics is about 30%, said Dr. Abreu, so the teduglutide response was significantly better.


Dr. Buchman said it was not clear just how teduglutide works. For example, the compound has a short half life, just 2 hours, a very high absolute bioavailability (87%), and it reaches its median peak concentration in 20 minutes to an hour, he said.


He proposed a number of potential mechanisms of action including, stimulation of crypt cell proliferation, inhibition of enterocyte apoptosis and stimulation of mesenteric blood flow.


But, these effects are observed even when "we can no longer detect teduglutide," he said. "So, we can't detect it, yet we see the results."


In an interview, he predicted on the basis of some open-label data, that teduglutide would be durable. "In the open label study, we don't see any dose erosion, which is a problem with the biologics because after a time you need to increase dose amount or frequency in order to maintain response. We are not seeing that effect."


The study was funded by NPS Pharmaceuticals. Dr. Buchman said NPS plans to use these data will be used to design a phase III study.



Primary source: Digestive Disease Week
Source reference:
Buchman, AL et al. "Effect of Teduglutide on Patients with Moderate-Severe Crohn's Disease after 8 Weeks of Therapy: A Prospective, Double-Blind, Placebo Controlled Trial" Abstract 686c.

http://www.medpagetoday.com/2005MeetingCoverage/2005DDWMeeting/dh/3368

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