OxThera Resumes Clinical Development of Hyperoxaluria Therapy
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
OxThera holds proprietary rights to pharmaceutical preparations and their use for
treatment of hyperoxaluria. Oxabact(R) 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(R) 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(R) 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(R) for the
treatment of primary hyperoxaluria, and Oxazyme(R), an oxalate decarboxylase, for the
prevention of oxalate malabsorption and recurring kidney stones in enteric hyperoxaluria.