Exhibit 99.1

 

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

— Initiated Phase 3 Study URIROX-1™ and Phase 2 Study 206 for ALLN-177 in Patients with Severe Hyperoxaluria —

— Reiterates Guidance for Key Objectives Across Portfolio—

NEWTON, Mass., May 8, 2018 – Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, clinical 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, 2018 and also provided a business update.

“Our accomplishments so far this year reflect our commitment to rapidly developing therapies for patients with severe metabolic and kidney-related disorders,” said Alexey Margolin, Ph.D., Chief Executive Officer of Allena Pharmaceuticals. “In the first quarter, we initiated URIROX-1™ and Study 206, two late-stage trials of ALLN-177 in patients with severe oxalate disorders, for whom safe and effective new medicines are urgently needed. Looking ahead, we are focused on advancing ALLN-177 as well as ALLN-346, our second product candidate for patients with hyperuricemia and chronic kidney disease, and remain on track to execute on our key objectives.”

Recent Business Highlights and Upcoming Milestones:

ALLN-177: ALLN-177 is a first-in-class, non-absorbed, orally-administered enzyme for the treatment of severe hyperoxaluria. Allena is currently evaluating ALLN-177 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 ALLN-177 in patients with enteric hyperoxaluria. URIROX-1 is designed with 90% power to show a treatment effect of at least 20 percentage points favoring ALLN-177 to placebo in the trial’s primary endpoint of percent change from baseline in 24-hour urinary oxalate excretion averaged during Weeks 1-4, comparing ALLN-177 to placebo. Allena continues to engage with the U.S. Food and Drug Administration (FDA) to finalize the design of URIROX-2™, the second, larger, planned Phase 3 clinical trial of ALLN-177 in patients with enteric hyperoxaluria. This proposed study is also designed to evaluate reduction in urinary oxalate excretion which could potentially form the basis for an accelerated approval filing. Under Allena’s proposed Phase 3 program, URIROX-2 would continue post approval, with the final results from the trial used to confirm clinical benefit. The proposed clinical data collected in this trial may include serial assessments for kidney stone disease progression and measures of kidney function. In addition to the Phase 3 program for enteric hyperoxaluria, Allena is also evaluating ALLN-177 in Study 206, a Phase 2 basket trial in adults and adolescents with primary hyperoxaluria or enteric hyperoxaluria with hyperoxalemia.

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

 

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

 

    Interim data from Study 206 in the second half of 2018;

 

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

ALLN-346: ALLN-346 is a first-in-class, orally-administered, urate-degrading enzyme in preclinical development for patients with hyperuricemia and moderate to severe CKD. These patients are challenging to manage due to limitations of existing therapies, such as poor tolerability, reduced efficacy, dose restriction or contraindications. Allena also reports continued progress toward its expected filing of an Investigational New Drug (IND) application for ALLN-346 in the first half of 2019.


The following information was filed by Allena Pharmaceuticals, Inc. (ALNA) on Tuesday, May 8, 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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