Study success appears to justify Ironwood’s VectivBio gamble
29 Feb 2024
Phase 3Clinical ResultAcquisitionNDA
Ironwood Pharmaceuticals’ $1-billion outlay on VectivBio looks to be paying off as the drug at the heart of the acquisition hit the primary endpoint of a Phase III study for short bowel syndrome, setting up marketing applications for the GLP-2 analogue.
The STARS trial evaluated once-weekly subcutaneous apraglutide in reducing parenteral support (PS) dependency in around 160 adults with short bowel syndrome with intestinal failure (SBS-IF). Top-line results showed that for the main goal, the relative change from baseline in actual weekly PS volume at week 24 was -25.5% for apraglutide versus -12.5% for placebo.
Ironwood added that apraglutide also demonstrated statistical significance for two key secondary endpoints, including days off PS and weekly PS volume. However, another two key secondary goals, which were specific to colon-in-continuity patients, were missed.
The drugmaker plans to submit the findings to the FDA and other regulatory bodies, as well as presenting further data at upcoming medical meetings.
More to come.
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