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Atlantic Phase III Setback Might Prompt Pouchitis Endpoint Rethink

 
• By Mike Ward

Despite failing to meet the co-primary endpoints in a Phase III trial, Atlantic Healthcare believes alicaforsen enema could still be approved in orphan-designated pouchitis.

3d render illustration of human digestive system - front view
Pouchitis Affects About 200,000 People in the US And Europe

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...

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