Allena Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Allena’s investigational therapy oxalate decarboxylase for the treatment of pediatric hyperoxaluria.
Allena’s lead compound ALLN-177, an oral formulation of oxalate decarboxylase, is being developed to treat patients with disorders of oxalate metabolism. Hyperoxaluria is a metabolic disorder characterized by excess excretion of oxalate in the urine. Pediatric hyperoxaluria has been associated with significant complications including kidney stones, nephrocalcinosis and kidney failure (end stage renal disease or ESRD).
“The granting of this designation highlights the increasing recognition that kidney stones and other complications of hyperoxaluria are a pediatric problem,” said Craig B. Langman, M.D., the Isaac A. Abt M.D. Professor of Kidney Diseases at Feinberg School of Medicine, Northwestern University and Head, Kidney Diseases at Lurie Children's Hospital of Chicago.
“A recent study looking at kidney stone incidence rates found that since 1996, the rate of kidney stones has been increasing across the population, but most among children ages 10-19. Given the recent and substantial increase in kidney stones among children, it is important to develop new therapies targeting hyperoxaluria, one of the key risk factors for recurrent kidney stones in children,” said Gregory Tasian, M.D. MSc, MSCE, Assistant Professor of Urology and Epidemiology at Perelman School of Medicine at the University of Pennsylvania and Attending Physician and co-Director of the Pediatric Kidney Stone Center at the Children’s Hospital of Philadelphia.
