OxThera Announces the Randomization of the First Patient Into its Phase III EPHEX Study With Oxabact

Stockholm (ots/PRNewswire) -

OxThera AB, a Stockholm-based privately-held biopharmaceutical
company with a product in late stage clinical development focusing
on Primary hyperoxaluria (PH), announces the randomization of the
first patient into its phase III study, EPHEX, with Oxabact.

Study OC5-DB-02 (EPHEX) is a randomized, placebo-controlled,
52-week study with the goal to investigate the efficacy and safety of
Oxabact in patients with PH. The purpose of the study is to show that
Oxabact can halt or delay the disease progression and preserve kidney
function.

"This is an important step for OxThera in developing a promising
treatment approach for patients suffering from Primary hyperoxaluria,
a devastating disease with high unmet medical need. With Oxabact, we
are attempting to reduce the systemic oxalate crystal burden and hope
to demonstrate that chronic treatment with Oxabact can preserve
kidney function for these patients," said Matthew Gantz, CEO of
OxThera.

Oxabact is an oral product, composed of highly concentrated
freeze-dried live bacteria (Oxalobacter formigenes). This commensal
bacteria promotes the enteric elimination of oxalate, thereby
reducing the oxalate burden in the kidneys. A complete clinical
development plan for Oxabact has been presented in Protocol
Assistance and End-of-Phase II meetings with EMA and FDA
respectively.

PH is a rare autosomal recessive disorder leading to markedly
elevated levels of endogenous oxalate causing kidney deterioration
and a gradual calcification of soft tissues. If left untreated, the
disease can cause kidney failure and premature death. Currently, the
sole available cure is a combined transplantation of liver and
kidneys.

Oxabact holds orphan drug designations in the EU and the US for
the treatment of PH, and in EU for treatment of Short Bowel Syndrome
(SBS).

About OxThera

OxThera holds worldwide rights for compositions and methods of use
for treatment of hyperoxaluria for two products; Oxabact and Oxazyme.

For further information, please contact

Matthew Gantz, +1-484-680-3001, or Elisabeth Lindner, COO of
OxThera AB, Phone +46-8-660-0223 or visit http://www.oxthera.com

ots Originaltext: OxThera AB
Im Internet recherchierbar: http://www.presseportal.de

Original-Content von: OxThera AB, übermittelt durch news aktuell