OxThera AB, a Stockholm-based privately-held biopharmaceutical company, today announced that it has initiated a clinical study in Primary Hyperoxaluria. This announcement bolsters the Company's position as a leader in developing therapies for hyperoxaluria, a debilitating condition that, if untreated, leads to kidney damage and end-stage renal disease.
"We are happy to announce that we have initiated our confirmatory clinical trial in Primary Hyperoxaluria", says Elisabeth Lindner, CEO of OxThera. "We are confident that our new Oxabact® product has potential in helping patients with this devastating disease ", Elisabeth Lindner continues.
The placebo-controlled clinical trial, OC5-DB-01, is conducted at 7 clinical sites in three countries and will include a total of 24 patients. Results are expected after summer next year. Oxabact® is an oral product composed of highly concentrated freeze-dried live bacteria (Oxalobacter formigenes), administered in capsules. The drug is designed for delivery to the small intestine where enteric elimination of endogenous oxalate is initiated. A complete clinical development plan for Oxabact® has been implemented for the treatment of patients suffering from Primary Hyperoxaluria.
Primary hyperoxaluria (PH) is a rare autosomal recessive disorder leading to markedly elevated levels of endogenous oxalate in plasma and urine. High levels of urinary oxalate cause kidney damage, including calcification of the kidney. If left untreated, the disease can cause kidney failure and premature death. The high medical need of PH is unmet to date. Currently, the sole available cure is a combined transplantation of liver and kidneys.
OxThera holds proprietary rights to pharmaceutical preparations and their use for treatment of hyperoxaluria. Oxabact® holds orphan drug designations in the EU and the US for the treatment of PH.