Addressing the Consequences of Toxic Metabolites

Allena Pharmaceuticals is developing non-absorbed oral enzyme therapeutics to treat metabolic conditions including hyperoxaluria and hyperuricemia. Addressing the toxic metabolite burden associated with these conditions may help reduce the risk of recurrent kidney stones (nephrolithiasis) and gout, diseases associated with inflammatory, renal and cardiac complications.

The company’s innovative approach enables the design and development of oral enzyme therapeutics that act in the gastrointestinal (GI) tract, where the enzymes exert their therapeutic effect by degrading a specific metabolite. The two programs currently in development focus on the metabolic compounds oxalate and uric acid. These metabolites are normal byproducts of cellular activity and are also derived from the normal diet. However, in certain circumstances they can build up and lead to complications such as hyperoxaluria and kidney stones in the case of oxalate, or hyperuricemia and gout in the case of uric acid.

Allena is also leveraging insights from the microbiome. The microbiome describes the wide range of bacteria that naturally live in the human body and perform helpful functions that native human cells are unable to do. Allena’s recombinant enzymes are sourced from bacteria that are able to target and degrade metabolic compounds.

Allena’s lead product candidate, ALLN-177, is being developed for the chronic management of hyperoxaluria, and there are two ongoing phase 2 clinical trials in adults.

The FDA has granted orphan-drug designation for ALLN-177 for the treatment of pediatric hyperoxaluria.

Allena’s second product in development, ALLN-346, is targeted toward hyperuricemia and treatment of gout.