Developing Therapeutics for Patients with Rare and Severe Metabolic and Kidney Disorders

Allena Pharmaceuticals is dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic disorders that affect the kidney. 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 technological approach enables the design, formulation and delivery of non-absorbed and stable enzymes orally and in sufficient doses for activity in the GI tract. This approach utilizes the GI tract to degrade metabolites, such as oxalate and urate, reducing plasma and urine levels, and in turn, reducing their disease burden on the kidney over time.

Reloxaliase (formerly ALLN-177), Allena’s lead product candidate, is a first-in-class, oral enzyme therapeutic in late-stage clinical development for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels due to either a genetic defect (primary) or from hyper-absorption of oxalate from the diet (secondary). Secondary hyperoxaluria can be due to an undefined cause (idiopathic) or as a result of underlying GI disorders (enteric). Kidney stones, often the first sign of hyperoxaluria, are painful and may require interventional procedures, for example. Severe hyperoxaluria in settings of enteric and primary hyperoxaluria may also damage the kidney and potentially lead to chronic kidney disease and end-stage renal disease. There are currently no approved therapies for the treatment of hyperoxaluria.

Allena has conducted a robust clinical development program of reloxaliase, including three Phase 2 clinical trials, which demonstrated reductions of urinary oxalate excretion in patients with secondary hyperoxaluria, especially in patients with enteric hyperoxaluria. Reloxaliase has also been well tolerated in clinical trials to date. Based on these data, the high unmet medical need, and the enzyme’s specific mechanism of action, Allena’ lead program is focused on adult patients with enteric hyperoxaluria.

The FDA also has granted separate orphan drug designations for reloxaliase for the treatment of primary hyperoxaluria and for the treatment of pediatric hyperoxaluria. In addition, the European Commission has granted orphan designation for reloxaliase for the treatment of primary hyperoxaluria.

ALLN-346, Allena’s second product candidate, 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.