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Allena Pharmaceuticals to Present New Data on Reloxaliase and ALLN-346 Development Programs at Upcoming ASN Kidney Week and ACR/ARP Annual Meeting

NEWTON, Mass., Oct. 17, 2019 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (ALNA), 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, today announced that it will present new data for reloxaliase, its first-in-class, oral enzyme for the treatment of hyperoxaluria, and for ALLN-346, its first-in-class, oral enzyme for the treatment of hyperuricemia in the setting of advanced chronic kidney disease (CKD) at upcoming medical meetings in November 2019.

“Our upcoming presentations highlight our ongoing efforts to develop oral enzyme therapeutics to degrade toxic metabolites and ultimately reduce kidney damage in patients living with excess oxalate or urate,” said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. “Due to limitations of existing therapies, there is a significant unmet need for these patient populations and we are committed to rapidly progressing reloxaliase and ALLN-346 through clinical development, as we seek to make a difference for people living with metabolic and kidney disorders.”

The accepted abstracts are listed below and are now available on the American Society of Nephrology (ASN) and American College of Rheumatology (ACR) conference websites, respectively: https://www.asn-online.org/education/kidneyweek/ and https://acrabstracts.org/.

American Society of Nephrology (ASN) Kidney Week 2019
November 5-10, 2019 in Washington, D.C.

Poster Presentations:

Title: Pilot study of reloxaliase in subjects with severe enteric hyperoxaluria and hyperoxalemia: A pro tem analysis of study ALLN-177-206
Session Title: CKD: Clinical, Outcomes, Trials - II
Session Date and Time: November 8, 2019, 10:00am – 12:00pm ET
Location: Exhibit Hall, Walter E. Washington Convention Center
Authors: Felix Knauf, John C. Lieske, Anja C. Pfau, Danica Grujic, Kristine E. Bernard, Annamaria T. Kausz
Abstract ID: FR-PO316

Title: Prevalence of kidney stones in patients with enteric disorders
Session Title: Bone and Mineral Metabolism: Calcium, Magnesium, Kidney Stones
Session Date and Time: November 9, 2019, 10:00am – 12:00pm ET
Location: Exhibit Hall, Walter E. Washington Convention Center
Authors: Gregory E. Tasian, Brandon B. Wade, Julia A. Gaebler, Annamaria T. Kausz, Joseph J.
Medicis, Christina M. Wyatt
Abstract ID: SA-PO276

Title: A phase 3, randomized, placebo controlled trial of reloxaliase in enteric hyperoxaluria (URIROX-1): Clinical characteristics and burden of illness
Session Title: Bone and Mineral Metabolism: Calcium, Magnesium, Kidney Stones
Session Date and Time: November 9, 2019, 10:00am – 12:00pm ET
Location: Exhibit Hall, Walter E. Washington Convention Center
Authors: John C. Lieske, James E. Lingeman, Pietro Manuel Ferraro, Zhiqun Zhang, Annamaria T.
Kausz
Abstract ID: SA-PO278

Title: Dietary oxalate ingestion, urinary oxalate levels, and response to reloxaliase in three Phase 2 studies
Session Title: Health Maintenance, Nutrition, Metabolism - II
Session Date and Time: November 9, 2019, 10:00am – 12:00pm ET
Location: Exhibit Hall, Walter E. Washington Convention Center
Authors: Craig B. Langman, Linda H. Easter, Zhiqun Zhang, Annamaria T. Kausz, Sagar U. Nigwekar
Abstract ID: SA-PO815

Title: Establishing safety and efficacy of reloxaliase in patients with enteric hyperoxaluria (URIROX-2)
Session Title: Informational Posters - III
Session Date and Time: November 9, 2019, 10:00am – 12:00pm ET
Location: Exhibit Hall, Walter E. Washington Convention Center
Authors: Annamaria T. Kausz, Gary C. Curhan, Gregory E. Tasian, Charles D. Scales
Abstract ID: INFO16-SA

American College of Rheumatology 2019 ACR/ARP Annual Meeting
November 8-13, 2019 in Atlanta, Georgia

Poster Presentation:

Title: Enteral administration of ALLN-346, a recombinant urate-degrading enzyme, decreases serum urate in a pig model of hyperuricemia
Session Title: Metabolic & Crystal Arthropathies Poster II: Clinical Trials & Basic Science
Session Date and Time: November 11, 2019, 9:00am – 11:00am ET
Location: Hall B5, Georgia World Congress Center
Authors: Danica Grujic, Kateryna Pierzynowska, Paulina Szczurek, Stefan Pierzynowski, Aditi Deshpande, Olha Drahanchuck, Nadia Mosiichuk, Jarek Wolinski
Abstract ID: 1223

About Reloxaliase
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 fourth quarter 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.

In January 2019, Allena announced that it reached alignment with the U.S. Food and Drug Administration (FDA) on both the design of URIROX-2 and its strategy to pursue a Biologics License Application (BLA) submission for reloxaliase in patients with enteric hyperoxaluria using the accelerated approval regulatory pathway.  

In March 2019, Allena announced an agreement with the Duke Clinical Research Institute (DCRI), a leading academic research institute within Duke University School of Medicine, to establish and lead an Academic Coordinating Center (ACC) in support of the URIROX-2 Phase 3 clinical trial and preparation for the potential launch of reloxaliase.

About ALLN-346
ALLN-346 is an orally administered, novel, engineered urate oxidase that has been optimized for stability in the gastrointestinal (GI) tract and high production yield. Allena has designed ALLN-346 to degrade urate in the GI tract and in turn, reduce the urate burden on the kidney and lower the risk of urate-related complications. ALLN-346 is targeted to lower serum uric acid in patients with CKD, whose renal function is decreased and who have diminished capacity for urinary excretion of uric acid.

About Allena Pharmaceuticals
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.

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