Exhibit 99.1

    

Allena Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Business Update

 

-- Entered into Agreement with Duke Clinical Research Institute (DCRI) to Support Phase 3 URIROX-2™ Trial and Promote Enteric Hyperoxaluria Disease Awareness –

 

-- All Clinical Programs Progressing on Track; Expect to Report Initial Data from Study 206 in Second Quarter and Topline Data from Phase 3 URIROX-1™ Trial in Second Half of 2019 –

 

-- Multiple Catalysts Expected Across Broader Pipeline in 2019 --

 

NEWTON, Mass., May 8, 2019

-- Allena Pharmaceuticals, Inc. (NASDAQ: 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 reported financial results for the first quarter ended March 31, 2019 and also provided a business update.

 

“Our progress in the first quarter highlights our position as pioneers in the development of oral enzyme therapeutics for the treatment of rare and severe metabolic diseases,” said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. “We achieved alignment with the U.S. Food and Drug Administration (FDA) on the design of URIROX-2 and on our strategy to pursue an accelerated approval for reloxaliase in patients with enteric hyperoxaluria.  We are continuing to enroll our ongoing clinical trials, with a focus on completing enrollment in URIROX-1. In addition, we are pleased to be collaborating with DCRI on URIROX-2 to better promote disease awareness, drive patient identification, and evaluate the health economic impact of reducing oxalate burden in patients with enteric hyperoxaluria, all of which should support the future potential launch of reloxaliase as the first therapeutic for these patients. Looking forward, we are excited to report data from the initial cohort of subjects from Study 206, expected in the second quarter, and topline data from URIROX-1, expected in the second half of the year.”

 

Recent Business Highlights and Upcoming Milestones:

 

Reloxaliase: Reloxaliase is a first-in-class, non-absorbed, orally-administered enzyme for the treatment of severe hyperoxaluria. Allena is currently evaluating reloxaliase in two ongoing 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. Allena plans to pursue a Biologics License Application (BLA) submission for reloxaliase using the accelerated approval regulatory pathway.

 

Allena is also evaluating reloxaliase in Study 206, a multi-center, open-label, single arm Phase 2 basket study of reloxaliase in adults and adolescents with primary hyperoxaluria or enteric hyperoxaluria with advanced chronic kidney disease (CKD) and elevated plasma oxalate.

 

 

In March 2019, Allena announced an agreement with DCRI to support its URIROX-2 Phase 3 clinical trial. Under the terms of the collaboration, DCRI will establish and lead an Academic Coordinating Center (ACC), which, in addition to providing independent oversight and assisting with investigator engagement, will support Allena’s ongoing efforts to prepare for the potential launch of reloxaliase.  The ACC will contribute scientific expertise and thought leadership to the data analysis and publication strategy, including research on the health economic impact of reducing oxalate burden in patients with enteric hyperoxaluria.

 

Allena expects to achieve the following key milestones for reloxaliase:

 

Report preliminary findings from Study 206 in June 2019;

 

Report topline data from the URIROX-1 Phase 3 clinical trial in the second half of 2019; and

 

Report topline data from Study 206 in the second half of 2019.

 


The following information was filed by Allena Pharmaceuticals, Inc. (ALNA) on Wednesday, May 8, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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