Sweden-based biopharmaceutical company OxThera has randomised the first patient in a Phase III trial, EPHEX, designed to evaluate the safety and efficacy of Oxabact in treating patients with primary hyperoxaluria (PH).
PH is a rare autosomal recessive disorder that causes significantly elevated levels of endogenous oxalate, causing kidney deterioration and a gradual calcification of soft tissues.
If not treated, the disease can lead to kidney failure and premature death.
The EPHEX trial is a randomised, placebo-controlled, 52-week study that aims to demonstrate Oxabact's ability to halt or delay the disease progression and preserve kidney function.
OxThera CEO Matthew Gantz said: “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.”
Oxabact is an oral solution composed of highly concentrated freeze-dried live bacteria (Oxalobacter formigenes).
This commensal bacteria is capable of promoting the enteric elimination of oxalate, thereby minimising the oxalate burden in the kidneys.
Last November, OxThera received two new US patents, three new European patents and patents in Canada, China, Hong-Kong, India and Japan for the treatment of hyperoxaluria.
The US patents US8900575 and US8940295 cover pharmaceutical compositions of oxalate decarboxylase.
The European patents EP2449098 cover pharmaceutical compositions of oxalate decarboxylase, while EP1771201 and EP1965816 cover pharmaceutical compositions of Oxalobacter formigenes.