New OxThera/Oxabact US patent granted
Stockholm – 25 February 2021. OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), announces that a new US patent has been granted for its product candidate Oxabact announces that a new US patent has been granted for its product candidate Oxabact, and for a method for the treatment or prevention of an oxalate-related disorder, such as hyperoxaluria.
The first formulation of Oxabact was patented and granted back in 1999. Since 2012, the company has developed a new, high-concentrated formulation of Oxabact designed to promote excretion of endogenous oxalate from blood plasma. The new formulation of Oxabact is under final Phase 3 clinical testing in patients with Primary hyperoxaluria.
“We are happy to announce that our Oxabact product now has another 20 years of patent coverage in the US.” said Matthew Gantz, CEO of OxThera. “Oxabact has great potential to become a new treatment for hyperoxaluria.”
US patent No. 10,765,709 “Compositions and methods for the treatment or prevention of oxalate-related disorders” stems from PCT/EP2017/064422 (publication WO2017216165) filed on 13 June 2017 and will last until 2037. Oxabact is the first-in-class product to specifically target excretion of oxalate from plasma into the GI tract to protect the kidney. Oxabact is composed of highly concentrated Oxalobacter formigenes cells, a bacterial species dependent on oxalate for its survival.
Primary hyperoxaluria is a rare autosomal recessive inherited disorder of glyoxylate metabolism that causes an endogenous overproduction of oxalate. Oxalate cannot be degraded in humans and is mostly eliminated by the kidneys. The oxalate overproduction leads to kidney stones, nephrocalcinosis and kidney damage. In the most severe form of PH, plasma oxalate (Pox) levels can increase markedly, depositing calcium oxalate in the kidneys and ultimately in organ systems throughout the body in a potentially life‑threatening process known as systemic oxalosis.
A phase 3 study with Oxabact (OC5-DB-02) with Pox as the primary endpoint, kidney function and kidney stone events as secondary endpoints along with a follow-up, extension study (OC5-OL-02) are currently ongoing in patients with Primary hyperoxaluria Type I-, II- and III with maintained renal function. First study results are expected in June 2021.
Oxabact has received orphan drug designation in the US and the EU for the treatment of Primary hyperoxaluria.
For further information, please contact:
Matthew Gantz, CEO
Oxabact is a bi-modal enteric biotherapy containing a lyophilized formulation of Oxalobacter formigenes, a non-pathogenic, oxalate-degrading bacterium. Oxabact is administered orally as a coated capsule. By promoting active and passive secretion of oxalate from the plasma into the gut, Oxabact is able to eliminate oxalate, thereby lowering the oxalate burden in the kidneys.
OxThera AB is a Swedish biopharma company developing a new treatment for Primary hyperoxaluria (PH) - a rare genetic and devastating disease with fatal outcomes.