OxThera's Oxabact For SBS Receives EMA Orphan Status

Swedish biopharmaceutical company OxThera announced that it has received Orphan Drug Designation from the European Medicines Agency (EMA) for Oxabact as treatment for Short Bowel Syndrome (SBS).

Oxabact is an oral enzyme containing a high concentration of the live bacteria Oxalobacter formigenes. The product targets the small intestine wherein it initiates enteric elimination of endogenous oxalate. Oxabact was granted Orphan Drug Designation in both the EU and U.S. for the treatment of Primary Hyperoxaluria. The company also received two new US patents and an Australian patent for Oxabact as treatment for PH.

Short bowel syndrome is an intestinal failure characterized by nutrient malabsorption, diarrhea, bowel dilation, and dysmobility. The condition affects around 20,000 in the EU and approximately 15,000 patients in the U.S.

The designation was granted by the EMA’s Committee on Orphan Medicinal Products (COMP) based on positive data from preclinical models and clinical data indicating that Oxabact may offer clinically significant benefits for patients with SBS. Orphan designation in the EU confers a number of benefits upon the drug sponsor including protocol assistance and market exclusivity once the drug has received approval for its indication.

“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 OxThera CEO Elisabeth Lindner.

Earlier this year the company reported its receipt of a SEK70m cash funding to advance its clinical program for Oxabact in primary hyperoxaluria. OxThera is currently conducting clinical trials for the indication at seven study sites across three countries. Results from the trial are expected to be released during autumn this year.