Ironwood Nabs Phase III Win, Still Sees Stock Nosedive

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Pictured: Illustration showing a downward graph trend/iStock, lerbank

Boston-based Ironwood Pharmaceuticals announced positive Phase III topline results Thursday for its drug apraglutide, a GLP-2 analog, but it wasn’t enough to impress investors. Ironwood’s stock was hit with an almost 40% reduction in its share price.

Apraglutide is designed to reduce parenteral support (PS) dependency in adults with short bowel syndrome (SBS) with intestinal failure, a rare disease that can cause organ failure.

According to Thursday’s results, the drug in the STARS trial reached the primary endpoint of relative change from the baseline in the actual weekly PS volume, with arpaglutide seeing an over 25% reduction versus 12% in the placebo group and earning a p-value of 0.001.

Four secondary endpoints that Ironwood presented showed that more patients in the “combined population” achieved at least one day or a week off PS relative to the baseline–43% versus 27.5% for the placebo  and had a p-value of 0.040. By contrast, with relative change improvement, arpaglutide scored a p-value of <0.001.

For the other endpoints, which included colon-in-continuity patients in assessing at least one day to a week of PS and enteral autonomy, Ironwood said that these were “not achieved.” The company noted that apraglutide was “numerically favorable” but not statistically significant in improving these endpoints.  

Nonetheless, the company is touting the results and plans on submitting an NDA and other regulatory filings, though a timeline has yet to be revealed.

“We believe these results demonstrate the potential for apraglutide to improve the standard of care for all adult patients with SBS dependent on parenteral support as the only GLP-2 with once-weekly administration, if approved. We are thankful to the patients and clinical investigators involved in the largest study of a GLP-2 analog in SBS-IF and will work with regulators on next steps with the goal of making apraglutide available to those living with this severe condition,” Ironwood CFO Michael Shetzline said in a statement.

Ironwood secured the drug in May 2023 as part of the $1 billion acquisition of VectivBio, which expanded its overall gastro portfolio.

However, Ironwood has a lot of competition in the SBS field, as Takeda’s Gattex has been approved since 2019. Meanwhile, Zealand Pharma and Entera Bio continue to advance with their own GLP-2 candidates for the condition.

Tyler Patchen is a staff writer at BioSpace. You can reach him at Follow him on LinkedIn.

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