Ironwood Pharmaceuticals, Inc. (IRWD) Monday said that based on a recent interaction with the U.S. Food and Drug Administration (FDA), a confirmatory Phase 3 study is required to seek approval of apraglutide for patients with short bowel syndrome (SBS) with intestinal failure (IF).
Parallelly, the company plans to explore strategic alternatives and has engaged Goldman Sachs & Co. LLC.
In preparation for the new drug application (NDA) submission, pharmacokinetic analysis indicated that the exposure and dose delivered in the STARS Phase 3 trial were lower than planned due to dose preparation and administration. The company plans to work with the FDA on the design of a confirmatory Phase 3 study and the regulatory path forward.
"We are focused on the best path forward to get apraglutide to market, which we believe still has the potential to be a blockbuster drug. Concurrently, we will be exploring strategic alternatives for the company in an effort to maximize stockholder value," said Tom McCourt, chief executive officer of Ironwood.
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