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12:00 AM
May 26, 2008
 |  BioCentury  |  Product Development

Tioga's prospective perspective

When Tioga Pharmaceuticals Inc. was formed in 2005, the plan was to operate in virtual mode while completing a Phase IIb trial of asimadoline to treat irritable bowel syndrome, and then decide whether to build the company or sell the product for a profit. Tioga reported data from the trial last week and is now shopping around to investors and pharma companies. Even though asimadoline missed the primary endpoint across all IBS patients, Tioga expects to be in a good bargaining position because it showed positive results in two prospectively defined subgroups.

"No drug has ever shown efficacy in two IBS subtypes, so it's not surprising to see differential responses. But it is encouraging to see any response in multiple subtypes," CMO Allen Mangel told BioCentury.

According to Tioga, meeting the primary endpoint - percent of months in which patients across all IBS subgroups reported adequate pain relief - was essentially a long shot, because IBS is actually three different disorders, and no drug has ever been approved for more than one of them.

"We thought it might work in all three, so that's why we had the primary endpoint that we did," CBO and General Counsel David Urso told BioCentury. "It was a Phase II study, so we were trying to identify...

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