Allena Pharmaceuticals Reports Second Quarter 2021 Financial Results and Recent Corporate Progress
10 Aug 2021
CollaborateFinancial StatementFirst in ClassAccelerated Approval
NEWTON, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) (“Allena” or the “Company”), a late-stage biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases, today reported financial results for the second quarter ended June 30, 2021 and highlighted recent corporate progress.
“This is an exciting time to advance our first-in-class, novel oral biologic platform,” commented Louis Brenner, M.D., President and Chief Executive Officer of Allena. “We have continued to progress our two clinical programs with the goal of addressing therapeutic needs for patients with rare and severe metabolic conditions for which current treatment options are limited. For our reloxaliase program, we recently announced that we expect to conduct the first interim analysis early next year for patients enrolled in URIROX-2 through November of this year. We believe that this will provide meaningful and timely feedback for the conduct and ultimate completion of the adaptive design trial in patients with enteric hyperoxaluria.”
Dr. Brenner continued, “In addition, after successfully completing two Phase 1 safety studies, we are focused on advancing ALLN-346 through Phase 2a studies as a potential treatment for patients with gout in the setting of chronic kidney disease. We expect to accelerate the development of ALLN-346, which has the potential to address an unmet need for gout patients as an alternative to currently available agents that are either dose-limited or contraindicated in patients with gout and chronic kidney disease due to safety and tolerability concerns. We look forward to reporting initial data from the Phase 2a program later this year.”
Recent Corporate Developments
Second Quarter 2021 Financial Results:
Year to Date 2021 (Six-Month) Financial Results:
About Allena Pharmaceuticals
Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company leveraging its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases. Allena’s lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1 multiple-ascending dose study recently completed and a Phase 2a program recently initiated.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the future clinical, regulatory and commercial potential of reloxaliase, statements regarding enrollment and the timing of the planned interim analysis in the URIROX-2 trial, the impact of an earlier initial interim analysis on the size and duration of the URIROX-2 trial, statements regarding Allena’s strategy of pursuing a BLA submission for reloxaliase based upon data from its URIROX program using the accelerated approval regulatory pathway, which strategy is predicated on the FDA’s agreement with our predictive model supporting a relationship between UOx levels and kidney stone formation rates, statements regarding Allena’s development of ALLN-346 including the timing of planned clinical trials and the announcement of topline data for these trials, and statements regarding Allena’s financial position and need for capital. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: market and other conditions, the timing for completion of Allena’s clinical trials of its product candidates, risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risks associated with Allena’s financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena’s dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Allena’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as well as discussions of potential risks, uncertainties and other important factors in Allena’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.
Investor Relations Contact:Ashley R. RobinsonLifeSci Advisors, LLCTel: 617-430-7577arr@lifesciadvisors.com
Media ContactAdam DaleyBerry & Company Public Relations212-253-8881adaley@berrypr.com
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