Here’s what you should know:
1. In a phase 2 study of 126 patients, Bekinda improved stool consistency response by 20.7 percent over a placebo. With results in hand, RedHill representatives met with the FDA to gain insight into the drug’s regulatory pathway.
2. As a result of the meeting, RedHill is launching two phase 3 studies and will attempt to accelerate global pharma partnership discussions.
3. RedHill Biopharma is potentially seeking a U.S.-based partner for co-promotion opportunities.
4. RedHill COO Gilead Raday said, “We are very pleased with the outcome of our meeting with the FDA, which provided clarity on the planned endpoints as well as other important aspects for the design of the pivotal Phase 3 studies to support potential [new drug application] filing.”
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