OxThera Announces Completion of Recruitment in Phase 3 ePHex Study With Oxabact® in Patients With Primary Hyperoxaluria

  • Published Month : Monday, 06 Apr 2020 04:00 pm

Oxabact is an investigational bi-modal enteric biotherapy containing a lyophilized formulation of Oxalobacter formigenes for the treatment of adults and children with primary hyperoxaluria (PH) of all types. The objective of the study is to treat PH and prevent or delay kidney deterioration.

OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), announced today that it has completed enrollment in its Oxabact ePHex phase III study.

Oxabact is an investigational bi-modal enteric biotherapy containing a lyophilized formulation of Oxalobacter formigenes for the treatment of adults and children with primary hyperoxaluria (PH) of all types. The objective of the study is to treat PH and prevent or delay kidney deterioration.

OxThera is on track to report top-line results from ePHex in mid 2021. The Company also announced completion of its 36-months Phase 2 clinical study in patients with PH and ESRD treated with intensive maintenance dialysis, and reiterated continued positive results previously presented at the 2020 American Society of Nephrology held in Washington, DC.

"We are pleased to have reached two important milestones for our Oxabact program in PH, timely completion of enrollment in ePHex – our 12-month Phase 3 pivotal study – and successful completion of our 36-month Phase 2 study with Oxabact in dialysis patients," said Matthew Gantz, CEO of OxThera. "We look forward to reporting topline results from the ePHex study in mid 2021.  We believe that Oxabact has the potential to provide a clinically meaningful treatment option for patients living with PH."

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