OxThera has initiated the extension part of a Phase III clinical trial of Oxabact in Primary Hyperoxaluria after the first patients completed the study.
During the extension part, all clinics participating in the placebo-controlled Phase III study, OC5-DB-02, will continue to treat patients for another two years.
OxThera expects topline results from the trial in the first quarter of 2021.
OxThera CEO Matthew Gantz said: “We are confident that our drug candidate Oxabact has potential to provide clinical benefit for patients with this devastating disease, and are delighted to announce that the enrolment to the ongoing Phase III study is approaching completion.”
Set to be conducted at ten clinical sites in Europe and the US, the study will enrol a total of 22 patients, with the last patient expected to be enrolled this year.
The rare autosomal recessive disorder Primary Hyperoxaluria will lead to markedly elevated levels of endogenous oxalate in plasma and urine.
High levels of oxalate can damage the kidney, including crystallisation of oxalate in tissues and in the kidney. The disease can also lead to premature death if it is not treated.
Oxabact is an oral drug candidate and is composed of highly concentrated freeze-dried live bacteria, administered in capsules. It will be delivered to the small intestine.
The ongoing Phase III study aims to confirm the product’s ability to improve secretion of oxalate from plasma to the gut.
The drug candidate holds rights to pharmaceutical preparations of enzymes and bacteria and their use to treat Hyperoxaluria. It also holds orphan drug designations in the EU and the US for the treatment of the disease.