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Zealand (ZEAL) Ends Enrollment in Short Bowel Syndrome Study

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Denmark-based Zealand Pharma A/S (ZEAL - Free Report) announced that it has completed enrollment of patients in the pivotal phase III EASE-SBS 1 study that is evaluating its long-acting GLP-2 analog, glepaglutide, for the potential treatment of short bowel syndrome (“SBS”).

Full data from the EASE-SBS 1 study is expected in the third quarter of 2022. If data from the study is found to be positive, the company plans to submit regulatory applications to the FDA seeking approval for glepaglutide.

The regulatory body has already granted an Orphan Drug designation to glepaglutide for treating SBS.

Shares of Zealand Pharma have plunged 44.5% in the past year compared with the industry’s decrease of 38%.

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The double-blind and placebo-controlled EASE-SBS 1 study is assessing glepaglutide for once or twice weekly administration with an autoinjector to address the given indication. The primary endpoint of the study is to check the absolute reduction in parenteral support achieved by the end of the study.

In order to mitigate the challenges in recruitment caused by the ongoing COVID outbreak, the company reduced the sample size of the EASE-SBS 1 study to 108 patients compared with the earlier sample size of 129 patients with SBS.

Per the company, in the EASE-SBS 1 study, patients with SBS will be treated with glepaglutide for six months, following which they will be given four years of follow-up treatment in the extension studies — EASE-SBS 2 and 3.

In the third quarter of 2021, the company initiated the phase IIIb EASE-SBS 4 study to evaluate the long-term effects of glepaglutide on intestinal fluid and energy uptake.

SBS is a chronic and severe condition wherein patients can experience life-threatening complications like sepsis, blood clots, liver damage and renal impairment. Hence if successfully developed and upon potential approval, glepaglutide can help treat people living with SBS.

Zacks Rank & Stocks to Consider

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