Soligenix shares decimated as firm puts hold on orBec development

New Jersey, USA-based Soligenix (OTCBB: SNGX) saw its shares plummet 85% to just $0.03 last week, after the company said that an independent Data Safety Monitoring Board (DSMB) recently completed a pre-specified interim analysis for safety and utility for Soligenix' confirmatory Phase III clinical trial of orBec, an oral formulation of beclomethasone dipropionate (BDP) in acute gastrointestinal graft-versus-host disease (GI GVHD), recommending that the study be stopped as it is highly unlikely to achieve the predetermined primary objective of efficacy based on the interim results.

No safety concerns were raised regarding orBec treatment, said Soligenix but, as a result of the DSMB’s recommendation, patient enrollment in the study will stop and the data will be analyzed.

“We are obviously disappointed with the outcome of the DSMB’s review,” stated Christopher Schaber, president and chief executive of Soligenix. “Over the coming weeks, we will be analyzing the data. At this point, we do not know why the primary efficacy endpoint was not demonstrated by orBec, as two prior studies with very similar designs demonstrated robust efficacy and clinically relevant results in essentially the same patient population.