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EMA grants orphan drug designation to Oxabact for short bowel syndrome
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The European Medicines Agency Committee for Orphan Medicinal Products has granted orphan drug designation to Oxabact for the treatment of short bowel syndrome, according to a company press release.
Oxabact (OxThera) is an orally administered agent with concentrated live Oxalobacter formigenes that already is designated as an orphan drug in the European Union and the US for treatment of primary hyperoxaluria. OxThera is currently pursuing a clinical development program for Oxabact for that indication, the release said.
The new designation comes in response to preclinical and preliminary clinical data that indicate efficacy of Oxabact for treatment of short bowel syndrome (SBS), a rare malabsorptive condition characterized by diarrhea, nutrient malabsorption, bowel dilation and dysmobility, and associated with significant morbidity, mortality, reduced quality of life and high cost burden, according to the release.
“We are happy to announce that Oxabact is now also recognized as a potential treatment for [SBS],” Elisabeth Lindner, CEO of OxThera, said in the release. “OxThera believes 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.”
An estimated 15,000 and 20,000 people have SBS in the US and EU, respectively, the release said.