Allena Pharmaceuticals Showcases Reloxaliase and Enteric Hyperoxaluria Program at OHF International Hyperoxaluria Workshop
“Allena’s strong presence at the
The four presentations are summarized below:
In the session on enteric hyperoxaluria, Allena’s Chief Medical Officer, Dr.
In the session on the industry pipeline, Allena’s President and Chief Executive Officer, Dr.
In the poster session, a case series of the first four subjects with EH and advanced CKD treated with reloxaliase in Study 206 will be presented. Study 206 is a multi-center, open-label, single-arm Phase 2 basket study, designed to evaluate reloxaliase in adult and pediatric patients suffering from the progression of enteric hyperoxaluria with advanced chronic kidney disease (CKD) or primary hyperoxaluria (PH), both of which can lead to systemic oxalosis.
In the family and patient advocacy panel, Allena will join other biotechnology companies developing potential therapies that target the common enemy of excess oxalate, which can lead to severe disease in high risk patient populations.
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. 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.
About Pivotal Phase 3 URIROX Program
Allena’s URIROX program consists of two pivotal Phase 3 trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria.
URIROX-1 is a multicenter, global, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of reloxaliase in an expected 124 patients for a four-week treatment period. Patients will be randomized 1:1 to reloxaliase vs. placebo and will take 284 mg (equivalent to 7,500 units) of reloxaliase or placebo with each meal or snack up to five times per day, consistent with the eating patterns of patients with enteric hyperoxaluria. Allena expects to report topline data from URIROX-1 in the second half of 2019.
URIROX-2 is a multicenter, global, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria, over a minimum treatment period of two years. The trial is designed to enroll 400 patients with 24-hour urine oxalate (UOx) excretion greater than or equal to 50 mg and a history of kidney stones, and will include patients with normal kidney function as well as chronic kidney disease.
The primary efficacy endpoint of URIROX-2 is the percent change from baseline in 24-hour UOx excretion during Weeks 1-4, comparing reduction in the average UOx excretion across Weeks 1-4 with reloxaliase to placebo, the same primary endpoint as URIROX-1. Secondary endpoints in URIROX-2 include the proportion of subjects with a ≥ 20% reduction from baseline in 24-hour UOx excretion during Weeks 1-4 and percent change from baseline in 24-hour UOx excretion during Weeks 16 to 24. The primary long-term efficacy endpoint to confirm clinical benefit is the proportion of subjects 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. Secondary long-term efficacy endpoints to confirm clinical benefit include change in eGFR from baseline and emergency room visits, hospitalizations or procedures for the management of kidney stones.
About Study 206
Study 206 is a multi-center, open-label, single-arm Phase 2 basket study, designed to evaluate reloxaliase in adult and pediatric patients suffering from the progression of EH with advanced CKD or PH, both of which can lead to systemic oxalosis. The clinical trial is designed to enroll between 15 and 20 patients aged 12 and older. Patients orally administer 7,500 units of reloxaliase with each meal or snack five times a day, for 12 consecutive weeks. The primary endpoints of the trial are change from baseline in 24-hour UOx excretion and POx levels.
This basket study is seeking to identify an efficacy signal in several high risk patient populations including enteric hyperoxaluria patients with CKD, kidney transplantation or dialysis dependence or patients with primary hyperoxaluria types 1, 2 or 3. UOx is being collected for patients who are not on dialysis. Data has been released on the first seven patients from the study. This includes the first four EH patients who demonstrated plasma oxalate (POx) reductions of 28% and 16%, compared to baseline, in the two patients not on dialysis, and 49% and 45% in the two patients on dialysis. In addition, for the two patients not on dialysis, 24 hour UOx excretion was reduced by 29% and 42%. The summary data showed a range of POx reduction from 16% to 49% with an average reduction of 35%, compared to baseline. This summary POx data corrects an inadvertent error in a press release issued on
Based on the treatment effect observed in these four EH patients, coupled with the unmet need and high risk of morbidity and mortality in EH patients with advanced CKD, Allena intends to focus further enrollment in Study 206 on patients with EH and CKD, kidney transplantation or dialysis dependence and patients with PH and compromised renal function. Allena expects to announce topline results from the trial in the second half of 2019.
- Lumlertgul et al, Kidney Int Rep 2018; 3:1363-1372.
- Waikar SS et al, JAMA Intern Med 2019; 179(4):542–551.
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.