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OxThera Presents Full 24-month Data for Oxabact® in Primary Hyperoxaluria Type 1 (PH1) Patients With ESRD at Kidney Week 2019
WASHINGTON, Nov. 7, 2019 /PRNewswire/ -- OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), today presents data from a 24-month interim analysis of an ongoing phase 2 trial evaluating Oxabact® in PH type 1 (PH1) patients with end stage renal disease (ESRD). The results showing a continued reduction in plasma oxalate levels and improved or stable cardiac function, are being presented today during a poster session at ASN Kidney Week 2019 in Washington DC.
Study OC5-OL-01 is evaluating Oxabact in PH1 patients with ESRD. Today, full data from the 24-month interim analysis of this ongoing study are being presented at the American Society of Nephrology Kidney Week, the world's premier nephrology meeting. The results show that two years of treatment with Oxabact reduced mean plasma oxalate (Pox) by approximately 40% in PH1 patients with ESRD, without intensification in their dialysis regimen. Mean total (bound and unbound) Pox was 158.3 μmol/L at baseline (n=8), 119.8 μmol/L at Week 52 (n=6), and was further reduced to 94.6 μmol/L at Week 104 (n=5). Patients also showed an improvement and stabilization in cardiac function. Left Ventricular Ejection Fraction (LVEF) improved from 51.6 % at baseline (n=8) to 59.8% at Week 52 (n=6) and 59.4% at Week 104 (n=5). Global Longitudinal Strain was -18.1% at baseline (n=8), -18.3% at Week 52 and 20.0% at Week 104 (n=5).
"These data continue to support Oxabact as a promising treatment for patients suffering from PH. We are very pleased to present these two-year data at such an important meeting, showing that Oxabact continues to reduce plasma oxalate levels, without the need to intensify dialysis regimens. Furthermore, cardiac function either remained stable or improved over the same time period. This is impressive given that the systemic oxalate load and cardiac function in this patient population usually worsens over time," said Matthew Gantz, CEO of OxThera.
"Subclinical myocardial disease is already present early in the disease course of PH patients, often with preserved LVEF. In patients with ESRD, overt systemic oxalosis can have detrimental effects on cardiac morbidity," said Prof. Patricia Pellikka, Chair of the Division of Cardiovascular Ultrasound at Mayo Clinic, Rochester, Minnesota. "I'm encouraged that 24-month treatment with Oxabact® continued to lower the oxalate load and was associated with stable cardiac function. It is very important that patients awaiting liver and/or renal transplantation are in good clinical condition."
Primary hyperoxaluria is a rare autosomal recessive disorder leading to markedly elevated levels of oxalate in plasma and urine. High levels of oxalate cause kidney damage, driven by the harmful effects of calcium-oxalate crystallization in kidneys and other tissues. If left untreated, the disease can cause kidney and cardiac failure and premature death. Oxabact is a bi-modal enteric biotherapy containing a lyophilized formulation of Oxalobacter formigenes, a non-pathogenic, oxalate-degrading commensal bacterium, administered as an oral capsule.
Study OC5-OL-01 is an ongoing study that enrolled patients into a long-term treatment phase of up to 3 years, or until liver/kidney transplantation. Oxabact was safe and well-tolerated. Most frequently reported adverse events (AE) were infections and infestations and gastrointestinal disorders. There were 5 serious AEs reported in 4 patients; none of these were considered related to Oxabact treatment by the investigator.
Session Title: Pediatric CKD
Session Date, Time: November 7, 2019, from 10:00 AM to 12:00 PM
Poster Board #: TH-PO766
Title: " Long-term Treatment with Oxabact OC5 Reduces Plasma Oxalate and Improves Cardiac Function in ESRD Patients with PH Type 1: a 24-month Interim Analysis"
Oxabact is a bi-modal enteric biotherapy containing a lyophilized formulation of Oxalobacter formigenes, a non-pathogenic, oxalate-degrading commensal bacterium. Oxabact is administered orally as a coated capsule. By promoting active and passive secretion of oxalate from the plasma into the gut, Oxabact potentials elimination of oxalate via the gut, lowering the oxalate burden in the kidneys.
OxThera AB is a Swedish biotech company developing a new treatment for primary hyperoxaluria (PH) - 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 investigational drug candidate Oxabact is ongoing in patients with PH Type I, II or III not on dialysis, and an application for registration is expected to be submitted in the second half of 2021. Oxabact has received orphan drug designation in the US and the EU for the treatment of PH.
For further information, please contact:
Matthew Gantz, CEO