Atlantic Phase III Setback Might Prompt Pouchitis Endpoint Rethink

Post-hoc analyses of data sets from Phase III clinical trials that failed to meet primary endpoints might look like grasping at straws but in orphan indications there maybe some justification. Executives at Atlantic Healthcare PLC are now looking at subsets of data from the Phase III trial of Camligo, its alicaforsen enema formulation, in patients with debilitating antibiotic-refractory pouchitis.

The Phase III, multi-center, double-blind randomized controlled trial focused on the effectiveness of Camligo (alicaforsen enema) in treating 138 patients with chronic antibiotic-refractory pouchitis at 40 centers across the US,...