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9 Meters Biopharma, Inc. Amends Definition of Primary Endpoint for Phase 3 Trial in Celiac Disease After Consultation with FDA
-New methodology enables a more capital-efficient study, with reduction in participants from 630 to 525 while maintaining statistical powering at 90%
-Continuous variable approach more aptly reflects change in celiac disease patient symptoms over trial duration
The trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of larazotide for patients with celiac disease who continue to experience gastrointestinal symptoms while following a gluten-free diet. The primary efficacy outcome of the study comprises the mean change from baseline on the CeD PRO rating scale abdominal domain over 12 weeks for two active treatment doses (0.25 mg and 0.50 mg) compared to placebo.
"We have adjusted our approach to the primary endpoint calculation after consultation with the FDA to utilize a continuous variable instead of a responder analysis. Consequently, we have reduced the size of the study population to 525 from the original 630, while maintaining the study's original 90% statistical powering," said
The trial is currently under way at over 100 clinical sites, with an interim analysis still anticipated during the first half of 2021 and topline data anticipated in the second half of 2021. For more information on the trial, please visit Clinicaltrials.gov: NCT03569007.
For more information, please visit www.9meters.com.
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