"Shocked" Soligenix halts futile Phase III of orBec in GvHD after years of struggle
This article was originally published in Scrip
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.