Exhibit 99.1

    

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

 

-- Global Phase 3 URIROX-1™ Trial Ongoing; Expect to Initiate Second Phase 3 Study, URIROX-2™, in 2018  --

 

-- Presented Preclinical Proof-of-Concept Data on ALLN-346 at American College of Rheumatology (ACR/ARHP) Annual Meeting and New Data Characterizing Unmet Need in Enteric Hyperoxaluria at ASN Kidney Week 2018 --

 

NEWTON, Mass., November 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 third quarter ended September 30, 2018 and also provided a business update.

 

“As new research emerges on oxalate’s damaging effects on the kidneys, we are encouraged by the growing awareness of enteric hyperoxaluria and widespread focus on addressing the significant burden of kidney stone disease and kidney damage that it causes. We are similarly pleased to see an increased recognition of the unmet need for new therapies to treat hyperuricemia in patients living with gout and CKD, who are not optimally managed by existing therapies,” said Alexey Margolin, Ph.D., Chief Executive Officer of Allena Pharmaceuticals. “By designing first-in-class enzyme therapeutics that target the underlying causes of these diseases, we believe we are positioned to meaningfully impact the treatment landscape for patients. We have been encouraged by our productive dialogue with the U.S. Food and Drug Administration (FDA) on the protocol and statistical plan for URIROX-2 and with the steady rate of enrollment in our ongoing URIROX-1 trial and Study 206. Looking ahead to 2019, we are excited to read out data from both our ongoing trials and to advance our clinical pipeline with ALLN-346, while continuing to drive understanding and awareness around the daily experience of people living with rare and severe metabolic and kidney disorders.”

 

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 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 reloxaliase in patients with enteric hyperoxaluria. Allena continues to engage with the FDA to finalize the protocol and statistical plan for URIROX-2, the second, larger, planned Phase 3 clinical trial of reloxaliase in patients with enteric hyperoxaluria, and to discuss the potential eligibility of reloxaliase for an accelerated approval pathway.  Allena’s most recent interaction with the FDA focused on two elements for the post-approval outcome phase of the trial. Allena is also evaluating reloxaliase in Study 206, a Phase 2 basket trial in adults and adolescents with primary hyperoxaluria or enteric hyperoxaluria with advanced chronic kidney disease (CKD) and elevated plasma oxalate.

 

 

In October 2018, Allena presented new data characterizing the significant unmet need in enteric hyperoxaluria in a poster session at ASN Kidney Week 2018 in San Diego, CA. The presentation included composite data, details on kidney stone burden, and case studies from 33 patients who enrolled across Allena’s three Phase 2 studies of reloxaliase. Data confirmed that a majority of these patients experienced persistently high 24-hour urinary oxalate excretion, despite following standard-of-care guidance for diet and hydration. Additionally, among 20 patients for whom kidney stone burden was assessed by CT scan, 16 had at least one kidney stone detected at enrollment, with an average of three stones present.  

 

Allena expects to achieve the following key milestones:

 

Pending ongoing interactions with the FDA, initiate URIROX-2 in 2018;

 

Present interim clinical data from Study 206 in the first half of 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, November 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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