Exhibit 99.1

    

 

Allena Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update

 

-- Enrollment ongoing in Phase 3 URIROX-2 clinical trial of reloxaliase; interim analysis expected 2Q or 3Q 2022 --

-- Enrolling healthy volunteers in Phase 1b MAD study of ALLN-346; initial data expected 3Q 2021 --

-- On-track to initiate Phase 2a program for ALLN-346 in 3Q 2021; initial data expected 4Q 2021 --

-- Company to host KOL webinar on the unmet need in gout and potential for ALLN-346 on June 16, 2021 --  

 

NEWTON, Mass., May 11, 2021 -- Allena Pharmaceuticals (NASDAQ:ALNA), a late-stage biopharmaceutical company dedicated to discovering, 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, 2021 and provided a business update.

 

“We are encouraged by the global relaunch of URIROX-2 and the lessening of the effects of the pandemic on the trial, as Q1 2021 was the most active quarter to date in terms of new site openings, subject screening and enrollment," said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. "Additionally, we continue to advance the development of ALLN-346, our second novel oral biologic, for the treatment of gout. We recently initiated our Phase 1 multiple-ascending dose study in healthy volunteers and we remain on track to initiate a Phase 2a program in patients with hyperuricemia during the third quarter. Because many of the currently available agents are either dose-limited or contraindicated in patients with gout and chronic kidney disease due to safety and tolerability concerns, we believe there is a substantial unmet medical need for a new therapy for these patients. We look forward to sharing additional detail on our clinical development program and the market opportunity for ALLN-346 at our key opinion leader webinar in June."

 

Allena today announced plans to host a key opinion leader webinar focused on the unmet need in gout in the setting of chronic kidney disease (CKD) and the potential for ALLN-346 as a first-in-class therapy.  The webinar will be held virtually on June 16, 2021 beginning at 12:00 p.m. ET. Scheduled to speak at the event is Robert Terkeltaub, M.D., Professor of Medicine, UC San Diego Medical School.  Additionally, Allena management will provide an overview of the market opportunity in gout and the ongoing clinical development program for ALLN-346. A live audio webcast of the event will be available under “Events and Presentations” in the Investors section of the Company’s website at www.allenapharma.com. More details for the event will be forthcoming.

 

Clinical-Stage Product Candidate Updates

 

Reloxaliase: Novel oral biologic for enteric hyperoxaluria

Reloxaliase is a first-in-class, non-absorbed, orally administered enzyme for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by high levels of urinary oxalate, which can lead to kidney stone disease and chronic kidney disease. There are currently no approved therapies for this disorder, which affects approximately 250,000 patients in the United States. Reloxaliase exerts its effect by breaking down oxalate in the gastrointestinal (GI) tract, reducing the absorption of dietary oxalate. Allena previously completed the URIROX-1 trial, the first of two pivotal Phase 3 clinical trials of reloxaliase, which demonstrated a statistically significant reduction in urinary oxalate levels, the primary endpoint of the study.

 

Allena is currently studying reloxaliase in the URIROX-2 trial, the second pivotal Phase 3 clinical trial in its URIROX program, with planned enrollment of 200 patients. The Company plans to conduct an interim analysis after 130 patients have been enrolled in the study for six months, currently expected to occur during the second or third quarter of 2022, with topline data becoming available approximately six months later. The U.S. Food and Drug Administration (FDA) has advised Allena that it agrees with the Company's strategy of pursuing a potential Biologics License Application (BLA) submission for reloxaliase based upon data from its URIROX program, including the completed URIROX-1 and ongoing URIROX-2 trials, using the accelerated approval regulatory pathway. To support

 


The following information was filed by Allena Pharmaceuticals, Inc. (ALNA) on Tuesday, May 11, 2021 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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