STOCKHOLM, June 7, 2012 /PRNewswire/ --
OxThera AB, a Stockholm-based privately-held biotechnology company, today announced that it has decided to resume clinical development in primary hyperoxaluria. Together with the company program investigating enteric hyperoxaluria, this announcement bolsters the Company's position as a leader in developing therapy for hyperoxaluria, a debilitating condition that leads to kidney damage and end-stage renal disease, if untreated.
"We are confident to provide confirmatory efficacy data from a pre-clinical study later this year. Following this, we will file clinical trial applications for a study in patients", says Elisabeth Lindner, new CEO of OxThera. "Our mapping of OxThera's previous scientific and clinical findings has elucidated several ways forward", Elisabeth Lindner continues.
OxThera holds proprietary rights to pharmaceutical preparations and their use for treatment of hyperoxaluria. Oxabact® is an oral product composed of highly concentrated freeze-dried live bacteria (Oxalobacter formigenes), administered in capsules. The drug is designed for delivery in the lower part of the small intestine where enteric elimination of endogenous oxalate is initiated. OxThera is currently discussing a complete clinical development plan for Oxabact® with regulatory agencies in the EU and in the US for the treatment of patients suffering from primary hyperoxaluria.
Primary hyperoxaluria (PH) is a rare autosomal recessive disorder leading to markedly elevated levels of endogenous oxalate in plasma and urine. High levels of urinary oxalate cause kidney damage, including stone formation and calcification of the kidney. If left untreated, the disease can cause kidney failure and premature death. The high medical need of PH is unmet to date. Currently, the sole available cure is a combined transplantation of liver and kidneys.
OxThera estimates that there are about 2,000 patients with primary hyperoxaluria in the Western world. Oxabact® holds orphan drug designations in the EU and the US for the treatment of PH.
OxThera holds worldwide rights for compositions and methods of use for treatment of hyperoxaluria. OxThera currently has two products in its pipeline: Oxabact® for the treatment of primary hyperoxaluria, and Oxazyme®, an oxalate decarboxylase, for the prevention of oxalate malabsorption and recurring kidney stones in enteric hyperoxaluria.