Allena announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for ALLN-177 (oxalate decarboxylase) for the treatment of primary hyperoxaluria (PH), a rare genetic disorder.
ALLN-177 is a first-in-class, oral, non-absorbed recombinant enzyme that exerts its action in the gastrointestinal tract where it breaks down dietary and endogenous oxalate. The removal of oxalate can help relieve the chronic oxalate burden in patients with PH and lower systemic levels for deposition as calcium oxalate crystals or as kidney stones.
The Orphan Drug designation was supported by data from preliminary studies showing that ALLN-177 significantly decreased urinary and plasma oxalate in several rodent and porcine models. Off-target adverse effects are thought to be reduced due to the high degree of enzyme specificity.
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