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Allena Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Business Update
-- Interim Data from Study 206 Demonstrated Substantial Treatment Effect in Patients with Enteric Hyperoxaluria and Advanced Chronic Kidney Disease, Including Robust Reductions in Both Urine and Plasma Oxalate–
-- Closed $10.0 Million Registered Direct Offering, Extending Cash Runway into the Fourth Quarter of 2020 –
-- Topline Data from Phase 3 URIROX-1 Trial and Study 206 On Track for the Second Half of 2019 --
NEWTON, Mass., August 7, 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 second quarter ended June 30, 2019 and also provided a business update.
“At Allena, we are committed to providing a first-in-class treatment for the full spectrum of patients with enteric hyperoxaluria (EH),” said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. “The initial data from Study 206 represent meaningful progress toward achieving this vision, as we showed for the first time reloxaliase’s ability to reduce both urine and plasma oxalate in patients with EH and impaired kidney function, including patients with advanced chronic kidney disease, dialysis-dependence, and transplantation. Importantly, these data are consistent with our prior clinical experience in enteric hyperoxaluria, increasing our confidence in our ongoing URIROX-1 trial and supporting our belief that reloxaliase’s mechanism of action can impact all stages of the disease. With a strengthened balance sheet following our registered direct offering, we look forward to advancing our two ongoing URIROX Phase 3 trials and to reporting topline data from URIROX-1 and Study 206 before year-end.”
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.
The URIROX program consists of two pivotal Phase 3 clinical trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with EH. The primary efficacy endpoint for both trials is the percent change from baseline in 24-hour urinary oxalate (UOx) excretion measured during Weeks 1-4, comparing reloxaliase to placebo. The primary long-term efficacy endpoint to confirm clinical benefit in URIROX-2 is the proportion of patients with kidney stone disease progression, defined as a composite of either symptomatic kidney stones or finding of new or enlarged kidney stones using imaging, over a minimum treatment period of two years. Allena expects to report topline data from URIROX-1 in the second half of 2019, and from URIROX-2 in the second half of 2021.
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 EH or primary hyperoxaluria (PH) with advanced chronic kidney disease (CKD) and elevated plasma oxalate. Patients orally administer 7,500 units of reloxaliase with each meal or snack five times a day, for 12 consecutive weeks. Allena expects to report topline data from Study 206 in the second half of 2019.
The following information was filed by Allena Pharmaceuticals, Inc. (ALNA) on Wednesday, August 7, 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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