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Tioga Pharmaceuticals' Asimadoline Demonstrates Positive Results in a Phase 2b Clinical Trial for the Treatment of Irritable Bowel Syndrome
Date:5/20/2008

Statistically Significant Reduction of IBS Pain and Normalizing Motility

Effect Observed

SAN DIEGO, May 20 /PRNewswire/ -- Tioga Pharmaceuticals, Inc. today announced the results of a recent Phase 2b study of its oral kappa opioid receptor agonist, asimadoline, which demonstrated statistically significant results in the treatment of Irritable Bowel Syndrome (IBS). Asimadoline produced significant improvement in diarrhea-predominant (D-IBS) and alternating (A-IBS) patients across multiple parameters including the primary endpoint of pain, as well as secondary endpoints of urgency, frequency and bloating in both males and females. In D-IBS patients, therapeutic benefit was observed within the first month of treatment and was sustained for the three month duration of the trial. Asimadoline appeared to be well tolerated with no adverse events occurring in a dose-dependent manner throughout the randomized, double-blind, placebo-controlled, dose-ranging clinical trial involving 596 subjects. These data were featured today in a late-breaking oral presentation session at the Digestive Disease Week 2008 Annual Meeting.

Study Results

Of the 596 patients randomized in the trial, approximately 33 percent were characterized as D-IBS, 37 percent constipation predominant (C-IBS) and 31 percent alternating between diarrhea and constipation (A-IBS).

-- In the overall patient group, patients with at least moderate pain

achieved a 17 percent improvement in percent number of months with

adequate relief of IBS pain compared to placebo (40 percent vs. 23

percent) with both the 0.5 mg (p=0.006) and the 1.0 mg (p=0.005) dose

of asimadoline.

- Evaluation by IBS subtype revealed benefit in D-IBS and A-IBS

patients.

- Benefit in C-IBS patients was not observed.

- The rate of adverse events was similar in asimadoline and placebo

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SOURCE Tioga Pharmaceuticals, Inc.
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