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news.Allena Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for its investigational therapy oxalate decarboxylase to treat pediatric hyperoxaluria.
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The company’s lead compound ALLN-177, an oral formulation of oxalate decarboxylase, is being developed to treat patients with disorders of oxalate metabolism.
Allena Pharmaceuticals COO Louis Brenner said: "We are encouraged by receiving this orphan designation from the FDA.
"This is an important step toward our goal of bringing ALLN-177 to pediatric and adult patients who suffer from oxalate disorders."
ALLN-177 is an orally-administered, recombinant oxalate-degrading enzyme in development for the chronic management of hyperoxaluria and kidney stones (nephrolithiasis).
It targets oxalate in the gastrointestinal tract in order to reduce the burden of both dietary and endogenously produced oxalate.
In phase I and phase 2 clinical trials, treatment with ALLN-177 resulted in a statistically significant reduction in urinary oxalate excretion.
ALLN-177, which is currently being tested in two clinical trials in adult secondary hyperoxaluria, has the potential to decrease the oxalate available systemically for deposition as calcium oxalate crystals or stones in the kidneys, as well as reduce the occurence of calcium oxalate related complications.
Hyperoxaluria is a common metabolic abnormality in pediatric patients with kidney stones. It causes due to high oxalate levels in the urine because of either hyper-absorption of oxalate from the diet or from overproduction of oxalate by the liver due to a genetic defect.