Allena Pharmaceuticals

Allena Pharmaceuticals, Inc. was a late-stage biopharmaceutical company that leveraged its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases. Its lead product candidate, reloxaliase, was evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels commonly associated with kidney stones, chronic kidney disease, and other serious kidney disorders. Reloxaliase exerted its effect by breaking down oxalate in the gastrointestinal (GI) tract, reducing the absorption of dietary oxalate.

Allena's second clinical candidate, ALLN-346, received Fast Track Designation from the US Food and Drug Administration (FDA) for the treatment of hyperuricemia and gout in the setting of advanced chronic kidney disease (CKD). ALLN-346 was a first-in-class, non-absorbed, orally administered enzyme designed to degrade urate in the GI tract without systemic absorption, thereby reducing systemic urate levels in patients with hyperuricemia, gout, and CKD.

In January 2022, ALLN-346 demonstrated a statistically significant reduction in serum uric acid and a well-tolerated safety profile in the first cohort of a Phase 2a study involving hyperuricemic patients with CKD. A positive correlation between serum uric acid reduction and the degree of renal impairment supported ALLN-346's GI mechanism of action.

Allena terminated operations and went out of business as its plan of liquidation became effective on June 20, 2023.