OxThera’s Oxabact Receives EMA’s Positive Decision on Pediatric Investigational Plan to Treat Primary Hyperoxaluria

Shots:

• The approval of the Pediatric Investigational Plan (PIP) is based on PDCO’s positive opinion for Oxabact (Oxalobacter formigenes) to treat pediatric patients with primary hyperoxaluria
• Oxabact is currently evaluated in an ongoing P-III PBO controlled clinical study across sites the US and Europe, monitoring the change in plasma oxalate and estimated glomerular filtration rate (eGFR) @12 mos., and will together with the follow-up study evaluating clinical benefits
• Oxabact is a bi-modal enteric biotherapy comprising a lyophilized formulation of Oxalobacter formigenes which is non-pathogenic, oxalate-degrading commensal bacterium and is administered orally as a coated capsule, act by promoting the secretion of oxalate from the plasma into the gut, eliminates oxalate via gut thus reducing the burden on kidneys

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