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OxThera Initiates Extension Part of a Phase 3 Study of Oxabact in Primary Hyperoxaluria
STOCKHOLM, June 20, 2019 /PRNewswire/ -- OxThera AB, a biopharmaceutical company dedicated to improve the lives of people living with Primary Hyperoxaluria, today announced that the first patients in a Phase 3 study of Oxabact® have completed the study and transitioned to an open-label extension part. All clinics participating in the study will continue to treat patients in the extension part for another two years. Topline results from the Phase 3 study are expected in the first quarter of 2021.
Primary Hyperoxaluria is a rare autosomal recessive disorder leading to markedly elevated levels of endogenous oxalate in plasma and urine. High levels of oxalate cause kidney damage, including crystallization of oxalate in tissues and in the kidney. If left untreated, the disease can cause kidney failure and premature death.
"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 3 study is approaching completion", says Matthew Gantz, CEO of OxThera.
The placebo-controlled Phase 3 study, OC5-DB-02, is conducted at 10 clinical sites in Europe and US and will enroll a total of 22 patients. Last patient is expected to enroll during 2019.
Oxabact® is an oral drug candidate composed of highly concentrated freeze-dried live bacteria (Oxalobacter formigenes), administered in capsules. The product is designed for delivery to the small intestine, and the ongoing Phase 3 study is aiming to confirm its ability to improve secretion of oxalate from plasma to the gut, where oxalate is broken down by the microbiome.
OxThera holds proprietary rights to pharmaceutical preparations of enzymes and bacteria and their use for treatment of Hyperoxaluria. Oxabact® holds orphan drug designations in the EU and the US for the treatment of Primary Hyperoxaluria.
OxThera AB is a Swedish biotech company developing a new treatment for primary hyperoxaluria - a rare genetic and devastating disease with fatal outcomes. Currently pharmaceutical treatment is not available and median age of death is 30. A phase 3 study of Oxthera's drug candidate Oxabact® is ongoing, and an application for registration is expected to be submitted in the second half of 2021. Oxabact® has received orphan drug status in the US and the EU.
For further information, please contact:
Matthew Gantz, CEO