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OxThera

Biotech & Life Sciences · Stockholm, Sweden · Founded 2005

OxThera, a biopharmaceutical firm headquartered in Stockholm, Sweden, was established in 2005 to develop treatments for the rare genetic disease primary hyperoxaluria (PH). The company's foundation is rooted in the 1970s research of microbiologist Milt Allison, who discovered that the bacterium *Oxalobacter formigenes* metabolizes oxalate, a substance that can cause severe kidney damage at high concentrations. This scientific observation led to the development of OxThera's primary product candidate, Oxabact®, a live biotherapeutic product. The company focuses on developing therapies for hyperoxaluria, a condition characterized by the over-accumulation of oxalate. Primary hyperoxaluria is a devastating disease, particularly affecting children, which can lead to progressive kidney damage and, ultimately, kidney failure. OxThera's business model centers on the clinical development and eventual commercialization of its product pipeline to address this unmet medical need. The firm operates in the rare disease and biopharmaceutical markets, targeting patients with primary and secondary hyperoxaluria. Revenue generation is anticipated through the sale of its approved drug candidates. The company has successfully raised significant capital to fund its development programs, including a €32 million investment to finance a pivotal Phase III study for Oxabact®. Oxabact® is an orally administered drug containing a freeze-dried, live formulation of the *Oxalobacter formigenes* bacteria. The product is designed to promote the secretion of oxalate from the blood into the gut, where the bacteria can degrade it. This mechanism aims to reduce the oxalate burden on the kidneys, thereby preventing further damage. The bacteria are protected by a special enteric coating that allows them to pass through the stomach and be released at their target site in the intestine. OxThera has also been developing a second product, Oxazyme®, an enzyme-based therapy designed to break down dietary oxalate. The company has secured orphan drug designations for Oxabact® in both the EU and the US for treating primary hyperoxaluria. Keywords: OxThera, primary hyperoxaluria, Oxabact, Oxalobacter formigenes, biopharmaceutical, rare disease, kidney disease, oxalate, enteric biotherapy, live biotherapeutic product, clinical trials, orphan drug, Stockholm, Milt Allison, Oxazyme, kidney failure, metabolic disorder, pediatric kidney disease, gut microbiome, oxalate degradation