Allena Pharmaceuticals Completes Enrollment in Pivotal Phase 3 URIROX-1 Trial Evaluating Reloxaliase in Patients with Enteric Hyperoxaluria
“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
About the URIROXProgram
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
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding Allena’s URIROX clinical program, statements regarding the timing of announcement of release of data from its ongoing clinical trials, statements regarding Allena’s ability to utilize the accelerated approval regulatory pathway for reloxaliase, statements regarding the ability of reloxaliase to provide clinical benefit to patients with hyperoxaluria, and statements regarding the clinical and commercial potential of reloxaliase for patients with hyperoxaluria. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that results of earlier studies, or interim results, may not be predictive of future clinical trial results, and planned and ongoing studies may not establish an adequate safety or efficacy profile for reloxaliase to support regulatory approval or the use of the accelerated approval regulatory pathway; risks related to Allena’s ability to utilize the accelerated approval pathway for reloxaliase, including the risk that available data at the time of any sample size re-estimation or interim analysis conducted during the URIROX-2 trial may not be sufficient to demonstrate an increased probability of kidney stone events in patients with enteric hyperoxaluria and increasing UOx levels; the risk that the
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Source: Allena Pharmaceuticals, Inc.