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"Shocked" Soligenix halts futile Phase III of orBec in GvHD after years of struggle

This article was originally published in Scrip

Executive Summary

Soligenix of the US, formerly known as DOR BioPharma, called a quick halt to enrolment in its confirmatory Phase III trial of its lead product, orBec (oral beclomethasone dipropionate), a locally acting corticosteroid to treat acute gastrointestinal graft-vs-host disease (GvHD). An interim analysis by the independent data safety monitoring board concluded that it is "highly unlikely" that orBec will meet the primary efficacy endpoint of showing a benefit in time to treatment failure through study day 80 versus placebo. No safety issues were cited.



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