Allena Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Trial

Allena Pharmaceuticals, Inc. recently announced it has completed enrollment in its pivotal Phase 3 URIROX-1 clinical trial. URIROX-1 is a multi-center, global, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of reloxaliase for the treatment of patients with enteric hyperoxaluria. The company expects to report topline data from the trial in the fourth quarter of 2019.

“We would like to thank the dedicated patients and physicians who helped us achieve this development milestone for our reloxaliase program. We are excited to complete enrollment in this Phase 3 trial, as it brings us one step closer to achieving our foundational goal of providing reloxaliase as a first-in-class therapy for patients with enteric hyperoxaluria. These patients suffer from the burden of excess oxalate, including kidney stones and kidney damage,” said Louis Brenner, MD, President and Chief Executive Officer of Allena Pharmaceuticals. “We look forward to reporting topline data from URIROX-1 in the fourth quarter, as we also continue to partner with the community to increase awareness of enteric hyperoxaluria and advance the ongoing URIROX-2 pivotal trial.”

The URIROX program consists of two pivotal Phase 3 clinical trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria. The primary efficacy endpoint for both trials is the percent change from baseline in 24-hour urinary oxalate (UOx) excretion measured during weeks 1-4, comparing reloxaliase to placebo. The primary long-term efficacy endpoint to confirm clinical benefit in URIROX-2 is the proportion of patients with kidney stone disease progression, defined as a composite of either symptomatic kidney stones or finding of new or enlarged kidney stones using imaging, over a minimum treatment period of two years. Allena expects to report topline data from URIROX-1 in the fourth quarter of 2019, and from URIROX-2 in the second half of 2021. The company plans to pursue a Biologics License Application (BLA) submission for reloxaliase using the accelerated approval regulatory pathway.

Reloxaliase is an orally administered, recombinant oxalate-degrading enzyme that is being developed for the treatment of hyperoxaluria. Reloxaliase targets oxalate in the GI tract in an effort to reduce the burden of both dietary and endogenously-produced oxalate. Reloxaliase has the potential to decrease the oxalate available systemically for deposition as calcium oxalate crystals or stones in the kidneys, as well as reduce long-term kidney complications. In addition, reloxaliase has been granted separate orphan drug designations by the U.S. Food and Drug Administration for the treatment of primary hyperoxaluria and for the treatment of pediatric hyperoxaluria. The European Commission has granted orphan drug designation for reloxaliase for the treatment of primary hyperoxaluria.

Hyperoxaluria is a metabolic disorder characterized by significantly elevated oxalate levels in the urine, due to either overproduction of oxalate by the liver from a genetic defect, called primary hyperoxaluria, or from the excess absorption of oxalate from the diet, called secondary hyperoxaluria. Secondary hyperoxaluria is further characterized either as enteric, resulting from a chronic and unremediable underlying gastrointestinal disorder associated with malabsorption, such as bariatric surgery complications or Crohn’s disease, which predisposes patients to excess oxalate absorption, or idiopathic, meaning the underlying cause is unknown. Kidney stones, typically the first sign of hyperoxaluria, are often painful and may require interventional procedures. Severe hyperoxaluria in settings of enteric and primary hyperoxaluria may also lead to kidney damage (nephrocalcinosis), chronic kidney disease and end-stage renal disease, which may lead to death.

Enteric hyperoxaluria is the more severe subset of secondary hyperoxaluria. Allena estimates that there are approximately 200,000 to 250,000 patients with enteric hyperoxaluria and kidney stones in the United States.

Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena’s lead product candidate, reloxaliase, is a first-in-class, oral enzyme therapeutic for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders.