Allena Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to ALLN-177 (oxalate decarboxylase) for the treatment of pediatric hyperoxaluria.

There are currently no approved pharmacologic treatments for hyperoxaluria, a condition resulting from high oxalate levels in the urine. This is either due to hyper-absorption of oxalate from the diet or due to a genetic defect causing oxalate overproduction by the liver. Hyperoxaluria can initially lead to the development of kidney stones, as well as more serious complications such as, nephrocalcinosis, chronic kidney disease, end-stage renal disease and dialysis.

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Two trials are currently ongoing for the treatment of hyperoxaluria in the adult population. A Phase 2b study is evaluating multiple doses of ALLN-177 in recurrent calcium oxalate kidney stone formers with hyperoxaluria, and an additional Phase 2 study is evaluating the safety and efficacy of a 28-day treatment of ALLN-177 for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria.

ALLN-177, an investigational, oral formulation of oxalate decarboxylase, is under development for the treatment of patients with disorders of oxalate metabolism.

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