Exhibit 99.1

Allena Pharmaceuticals Reports Second Quarter 2018 Financial Results and Provides Business Update

– Enrolling Global Phase 3 URIROX-1 Trial; Plan to Initiate URIROX-2 in 2H18 –

– Treated First Patients in Phase 2 Basket Study of Reloxiliase (ALLN-177) for Primary Hyperoxaluria or

Enteric Hyperoxaluria with Advanced Chronic Kidney Disease (CKD) –

– Completed Animal Proof-of-Concept Study Supporting Selection of ALLN-346 as Lead Product Candidate

for Hyperuricemia in Patients with Gout and CKD –

– Reiterates Guidance Based on Progress Toward Key Objectives Across Portfolio –

NEWTON, Mass., August 7, 2018 — 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 second quarter ended June 30, 2018 and also provided a business update.

“Our second quarter and recent accomplishments demonstrate significant progress across our pipeline of proprietary oral enzyme product candidates. We continue to execute against our key objectives for 2018, ” said Alexey Margolin, Ph.D., Chief Executive Officer of Allena Pharmaceuticals. “We have continued activating sites globally for our URIROX-1 study of reloxiliase in enteric hyperoxaluria and are encouraged by the initial enrollment. Based on constructive engagement with the U.S. Food and Drug Administration (FDA), we have also begun start-up activities for URIROX-2, including entering into an agreement with our contract research organization, and continue to expect to initiate this trial in the second half of the year. Additionally, we treated the first patients in our Phase 2 basket trial of reloxiliase in the most severe forms of hyperoxaluria. We have also expanded our pipeline with the selection of ALLN-346 as our lead product candidate for the treatment of hyperuricemia in patients with gout and CKD. We are committed to building out our product pipeline to address a broad range of severe metabolic and kidney-related disorders and believe we have made important strides towards this goal year-to-date.”

Recent Business Highlights and Upcoming Milestones:

Reloxiliase (ALLN-177): Reloxiliase, also known as ALLN-177, is a first-in-class, non-absorbed, orally-administered enzyme for the treatment of severe hyperoxaluria. Allena is currently evaluating reloxiliase in URIROX-1, the first of two anticipated Phase 3 clinical trials intended to support a potential accelerated approval filing of a Biologic License Application (BLA) for reloxiliase in patients with enteric hyperoxaluria. Allena continues to engage with the FDA to finalize the design of URIROX-2, the second, larger, planned Phase 3 clinical trial of reloxiliase in patients with enteric hyperoxaluria, and to discuss the potential eligibility of ALLN-177 for an accelerated approval pathway. In addition, the Company is evaluating reloxiliase in Study 206, a Phase 2 basket trial in adults and adolescents with primary hyperoxaluria or enteric hyperoxaluria with advanced CKD and elevated plasma oxalate.

 

   

In July 2018, Allena announced the treatment of the first patients in Study 206. The multi-center, open-label, single arm study is enrolling between 15 and 20 patients ages 12 and older in the U.S. and Europe for treatment with reloxiliase for 12 consecutive weeks. Clinical trial sites in the U.S. are enrolling patients, and investigators are preparing to enroll patients at European sites in the third quarter of 2018.

Consistent with prior guidance, Allena expects to achieve the following key milestones:

 

   

Pending ongoing interactions with the FDA, initiate the URIROX-2 Phase 3 clinical trial in the second half of 2018;

 

   

Report interim data from Study 206 in the second half of 2018; and

 

   

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


The following information was filed by Allena Pharmaceuticals, Inc. (ALNA) on Tuesday, August 7, 2018 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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