Tioga Pharmaceuticals' Asimadoline Demonstrates Positive Results in a Phase 2b Clinical Trial for the Treatment of Irritable Bowe...(p treated subjects. -- Patien...),Health

-- Patients with D-IBS with at least moderate pain achieved a 27 percent

improvement in the percent number of months with adequate relief of

IBS pain compared to placebo (47 percent vs. 20 percent, p=0.011) with

the 0.5mg dose of asimadoline.

- A 25 percent increase in pain free days was seen with 0.5 mg

asimadoline as compared with placebo (p=0.001) during the 12-week

dosing period. This represents an increase of approximately 20

pain free days over that seen with placebo.

- Statistically significant (p<0.05) improvement in pain was seen by

week three and persisted for the duration of treatment.

- Statistically significant improvements were also seen in D-IBS

patients receiving the 0.5 mg dose of asimadoline in all of the

following secondary endpoints: urgency, adequate relief of IBS

symptoms, stool frequency, bloating and daily pain. Statistically

significant improvement was also seen in urgency, adequate relief

of IBS symptoms, bloating and daily pain in patients receiving

the 1.0 mg dose.

- Benefit was seen in female and male patients.

-- Patients with A-IBS with at least moderate pain achieved a 23 percent

improvement in the percent number of months with adequate relief of

IBS pain compared to placebo (50 percent vs. 27 percent, p=0.022) with

a 1.0 mg dose of asimadoline.

- Statistically significant benefit was also seen in the secondary

endpoint of adequate relief of IBS symptoms in patients receiving

the 1.0 mg dose of asimadoline compared to placebo (57 percent vs.

33 percent, p=0.032).

- Benefit was seen in female and male patients.

Study Design

D-IBS, C-IBS, and A-IBS patients were recruit
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