Company announcement – No. 3 / 2022
- Full trial results of EASE-SBS 1 expected in the third quarter of 2022
- Pending positive pivotal data, Zealand intends to file for marketing approval with the U.S. Food and
Drug Administration
The trial sample size has been reduced to approximately 108 patients from the original sample size of 129 patients to mitigate expected recruitment challenges caused by the renewed COVID outbreak. The trial will have 95% power (versus the original 98%) to detect a treatment effect on the primary endpoint. Due to the current plan, extent of patient roll-over into long-term extension trials, and prolonged follow-up caused by COVID disruptions, the cumulative exposure to glepaglutide at the time of the potential NDA submission will be larger than originally anticipated at the End of Phase 2 meeting with the
Full results of the trial are expected in the third quarter of 2022 as a result of increased recruitment over the recent months. The previously announced interim analysis is therefore no longer required, preserving statistical power for the full analysis.
“We are very pleased to have achieved this important milestone for
With completion of patient enrollment into EASE-SBS 1, the EASE-SBS 2 extension trial has been amended to allow for direct enrollment without prior participation in EASE-SBS 1. The EASE-SBS 2 trial is a two-year Phase 3b trial assessing safety and efficacy of glepaglutide dosed once and twice weekly. In this long term safety study, there is no placebo arm.
About Short Bowel Syndrome (SBS)
SBS is a complex chronic and severe condition associated with reduced or complete loss of intestinal function. Many patients have to be connected to infusion lines and pumps every day, which pose significant restrictions on their ability to engage in daily activities. In addition, they are at risk of experiencing a number of serious and life-threatening complications such as sepsis, blood clots, liver damage and renal impairment.
About Glepaglutide
Glepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is being developed as a liquid product in an autoinjector designed for subcutaneous administration, aimed to reduce, or eliminate, the need for parenteral support in people living with SBS. The pivotal Phase 3 trial, EASE-SBS 1, with enrollment of up to 108 patients with SBS, is a randomized, double-blind and placebo-controlled study, with both once- and twice-weekly dosing regimens. The primary endpoint in EASE-SBS 1 is the absolute reduction in parenteral support achieved by the end of the trial. Patients will be treated for six months in EASE-SBS 1, whereafter they are offered four years continuous follow-up treatment with glepaglutide in the extension trials, EASE-SBS 2 and 3. A Phase 3b trial, EASE-SBS 4, was initiated in Q3 2021 and will assess long-term effects of glepaglutide on intestinal fluid and energy uptake.The
About
Zealand was founded in 1998 in
Forward-Looking Statement
This press release contains “forward-looking statements”, as that terms is defined in the Private Securities Litigation Reform Act of 1995, as amended, that provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, the occurrence of adverse safety events; risks of unexpected costs or delays; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release and are based on information available to
For further information, please contact:
Zealand Pharma Investor Relations |
Maeve Conneighton |
investors@zealandpharma.com |
Zealand Pharma Media Relations |
media@zealandpharma.com |
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