Focus

Treating Rare and Severe Metabolic Disorders that Impact the Kidney

Allena Pharmaceuticals is dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders.  The company is focused on metabolic disorders that result in excess accumulation of certain metabolites, such as oxalate and urate, that can cause kidney stones, damage the kidney, and potentially lead to chronic kidney disease, or CKD, and end-stage renal disease. 

Allena’s proprietary know-how in enzyme technology allow the company to design, formulate and deliver non-absorbed and stable enzymes orally and in sufficient doses for activity in the GI tract.  This approach enables the company to develop enzyme therapies that degrade metabolites, such as oxalate and urate, within the GI tract, thereby preventing their absorption, which reduces potentially toxic metabolite levels in the blood and urine, and in turn, diminishes the disease burden on the kidney over time.

ALLN-177, the lead product candidate, is a first-in-class, oral enzyme therapeutic in clinical development for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, CKD and other serious kidney diseases. There are currently no approved therapies for the treatment of hyperoxaluria.

The FDA has granted orphan-drug designation for ALLN-177 for the treatment of pediatric hyperoxaluria and primary hyperoxaluria. The European Commission has also granted orphan designation for ALLN-177 for the treatment of primary hyperoxaluria.

The company’s second product candidate, ALLN-346, is being developed for patients with hyperuricemia and moderate to severe CKD. Hyperuricemia, or elevated levels of uric acid in the blood, is commonly associated with gout as well as kidney stones and kidney disorders.