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Allena Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Business Update
Reported Positive Topline Results from Pivotal Phase 3 URIROX-1 Trial of Reloxaliase in Enteric Hyperoxaluria (EH), with Statistically Significant Reduction in Urinary Oxalate (UOx) Compared to Placebo
Reported Positive Data from Study 206 of Reloxaliase, Demonstrating Substantial Plasma Oxalate (POx) and UOx Reductions in Patients with EH and Advanced Chronic Kidney Disease (CKD)
Plan to Pursue Accelerated Approval Based on URIROX-1 Data and Results of 24-Week Data from URIROX- 2
Exploring Registrational Path for Reloxaliase in High-Risk EH Patients with CKD
NEWTON, Mass., November 13, 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 third quarter ended September 30, 2019 and also provided a business update.
We are excited about the presentation of positive topline results from URIROX-1 and Study 206 in EH patients that we presented at the American Society of Nephrology (ASN) Annual Meeting, said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. As we engaged with key opinion leaders at the meeting, we were encouraged by the positive reception to reloxaliases consistent treatment effect across URIROX-1 and our Phase 2 studies, and reminded of the tremendous unmet need facing patients living with EH, for whom there are no approved therapies today. These interactions reinforced our confidence in reloxaliases emerging therapeutic profile and potential as a first-in-class treatment for EH. We look forward to further analyzing the datasets from URIROX-1 and Study 206 and applying these insights to increase the likelihood of success in URIROX-2, and to inform our engagement with the U.S. Food and Drug Administration (FDA) as we explore the registrational path for reloxaliase in EH patients with advanced CKD.
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 for patients with EH in the pivotal Phase 3 URIROX program, and for patients with EH and advanced CKD and elevated POx in the Phase 2 Study 206.
At the American Society of Nephrology (ASN) Annual Meeting in November 2019, Allena presented positive topline results from its first pivotal Phase 3 trial, URIROX-1.
URIROX-1 achieved its primary endpoint, with a mean reduction of 22.6% in average 24-hour UOx excretion measured during Weeks 1-4 in patients on reloxaliase, compared to 9.7% in patients on placebo (least square (LS) mean treatment difference of -14.3%,. p=0.004).
The study approached statistical significance on the lead secondary endpoint, with 48.3% of patients on reloxaliase achieving a ³20% reduction from baseline in 24-hour UOx excretion, compared to 31.6% of patients on placebo (p=0.06).
In a pre-specified analysis of bariatric surgery patients (68% of the total study population), patients treated with reloxaliase achieved a mean reduction of 21.2% in average 24-hour UOx excretion, compared to 6.0% for patients treated with placebo (LS mean difference of -16.2%, p=0.01). In the stratified analysis of the key secondary endpoint, 50.0% of patients on reloxaliase achieved a ³20% reduction from baseline in 24-hour UOx excretion, compared to 28.9% of patients on placebo (p=0.036).
Consistent with prior clinical experience, reloxaliase was well-tolerated.
The following information was filed by Allena Pharmaceuticals, Inc. (ALNA) on Wednesday, November 13, 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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