Allena Pharmaceuticals Announces Interim Results from Study 206 of Reloxaliase in High Risk Patients with Advanced Oxalate Disorders
-- Substantial Treatment Effect Observed in Patients with Enteric Hyperoxaluria, Including Robust Reductions in Both Urine and Plasma Oxalate –
-- Reloxaliase Well-Tolerated Over 12 Weeks of Dosing --
-- Detailed Results to be Presented at
“We are pleased to see a robust response to reloxaliase in EH patients suffering from advanced stages of the disease. We believe this reflects reloxaliase’s activity and novel mechanism of action of degrading oxalate within the GI tract, which is well-targeted to treat excess oxalate absorption driven by an underlying GI disorder. The potential to alleviate the high oxalate burden on these patients is very encouraging,” said
Interim Data from Study 206
Study 206 is a multi-center, open-label, single-arm Phase 2 clinical trial designed to enroll between 15 and 20 patients in
The first seven patients have completed treatment, including one EH patient with advanced CKD, one EH patient with a functioning kidney transplant and two patients with EH who are on dialysis. Three patients had PH and preserved renal function.
- All four patients with EH experienced a reduction in POx, with an average reduction of 35% compared to baseline (range 16% to 49%). The two patients not on dialysis also experienced reductions in UOx of 29% and 42%, respectively. The treatment effect observed in these EH patients supports a continued focus on treating EH patients with CKD, kidney transplantation or dialysis dependence in an effort to reduce further oxalate damage.
- Three patients with PH type 2 or PH type 3 with preserved renal function were treated. These are the first patients with any form of PH treated with reloxaliase. One patient had a >20% mean reduction in UOx excretion, while the other two patients did not show a response to reloxaliase. Allena intends to narrow its further evaluation of reloxaliase in PH to patients with compromised renal function where the GI mechanism of action may play a more important role.
- This trial encompasses the longest reloxaliase treatment duration thus far. All patient populations are being treated for three months with more frequent dosing of reloxaliase than the Company’s prior Phase 2 studies (7,500 units of reloxaliase, five times per day). Average patient dosing compliance was greater than 90%. Treatment with reloxaliase was well-tolerated in all patient populations, with no reported treatment-related serious adverse events.
“I am extremely encouraged by the interim data from Study 206. People living with EH and significant renal compromise suffer from underlying GI conditions, which perpetuate a vicious and potentially fatal cycle of kidney damage, transplantation and return to dialysis, and there are no approved therapies available with which to treat them,” said
About Hyperoxaluria and Systemic Oxalosis
Hyperoxaluria is a metabolic disorder characterized by elevated urinary oxalate levels that may be due to either overproduction of oxalate by the liver from a genetic defect, known as primary hyperoxaluria, or from the excess absorption of oxalate from the diet, known as secondary hyperoxaluria. Secondary hyperoxaluria is further characterized either as enteric, resulting from a chronic and unremediable underlying GI disorder, or idiopathic, meaning the underlying cause is unknown. Systemic oxalosis occurs when excess oxalate is present throughout the body including the blood, kidney, bones, joints, eyes and heart. People living with systemic oxalosis have varying degrees of renal impairment including kidney stones, nephrocalcinosis, chronic kidney disease, and end-stage renal disease. For more information about the disorder and videos featuring patient stories, visit http://www.allenapharma.com/systemic-oxalosis.
Reloxaliase is an orally-administered, recombinant oxalate-degrading enzyme that is being developed for the treatment of severe 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. Reloxaliase is being evaluated in the ongoing pivotal Phase 3 URIROX-1 and URIROX-2 trials for patients with enteric hyperoxaluria and the ongoing Phase 2 basket trial for adult and pediatric patients suffering from primary hyperoxaluria or enteric hyperoxaluria with advanced chronic kidney disease. 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.
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the results of Study 206 and the clinical and commercial potential of reloxaliase for patients with primary hyperoxaluria or enteric 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 interim results or results of earlier studies 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.