Sep 23 2014
SBS is a highly disabling malabsorptive condition. SBS is associated with significant morbidity and mortality, reduced quality of life and high healthcare costs.
"We are happy to announce that Oxabact® is now also recognized as a potential treatment for Short Bowel Syndrome. OxThera believe that Oxabact® would be an excellent add-on therapy in SBS patients and would help the underlying gastritis and malabsorption in the gut, as well as subsequently reducing plasma oxalate and preventing kidney disease," said Elisabeth Lindner, CEO of OxThera.
EMA/Committee on Orphan Medicinal Products (COMP) considered that OxThera had provided data from preclinical models and preliminary clinical data, suggesting favourable effects of Oxabact® in SBS. The Committee considered that this may translate into clinically relevant benefit for patients affected by the condition.
Oxabact® is an oral product composed of highly concentrated live bacteria (Oxalobacter formigenes). OxThera is currently pursuing a complete clinical development program in the EU and in the US for the treatment of patients suffering from Primary Hyperoxaluria.
Oxabact® previously holds orphan drug designations in the EU and the US for the treatment of Primary Hyperoxaluria.