OxThera Resumes Clinical Development of Hyperoxaluria Therapy

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• Publié par: oxthera
• Nombre de lectures: 15
• Langue: English

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OxThera Resumes Clinical Development of

Hyperoxaluria Therapy

PR Newswire

STOCKHOLM, June 7, 2012

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.

About OxThera

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.

http://www.oxthera.com