{"id":453432,"date":"2021-03-09T07:03:28","date_gmt":"2021-03-09T12:03:28","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=453432"},"modified":"2021-03-09T07:03:28","modified_gmt":"2021-03-09T12:03:28","slug":"allena-pharmaceuticals-reports-fourth-quarter-and-full-year-2020-financial-results-and-provides-business-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/allena-pharmaceuticals-reports-fourth-quarter-and-full-year-2020-financial-results-and-provides-business-update\/","title":{"rendered":"Allena Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update"},"content":{"rendered":"
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\u00a0 \u00a0\u00a0— Reloxaliase continues to progress through ongoing pivotal Phase 3 URIROX-2 trial for enteric hyperoxaluria —<\/em><\/p>\n

\n — ALLN-346 poised to enter Phase 1 multiple-ascending dose and Phase 2a trials for hyperuricemia and gout —<\/em>\n <\/p>\n

\n — Management team strengthened with addition of David Clark, M.D., M.R.C.P as Chief Medical Officer and Richard Katz, M.D. as Chief Financial Officer —<\/em>\n <\/p>\n

NEWTON, Mass., March 09, 2021 (GLOBE NEWSWIRE) — 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 fourth quarter and full year ended\u00a0December 31, 2020\u00a0and provided a business update.<\/p>\n

\u201cBuilding on the significant accomplishments of 2020, we are entering 2021 well-positioned to execute on our mission of delivering novel oral biologic medicines to patients with rare and serious metabolic and kidney diseases,\u201d said Louis Brenner, M.D, President and Chief Executive Officer of Allena Pharmaceuticals. \u201cWe successfully reinvigorated our global Phase 3 URIROX-2 clinical trial of reloxaliase for the treatment of enteric hyperoxaluria, a life-threatening disease for which there is no currently approved therapy. In addition, we initiated clinical development of ALLN-346 for the treatment of hyperuricemia and gout, our second oral biologic program, further demonstrating the potential broad applicability of our technology platform.”<\/p>\n

Dr. Brenner continued, \u201cAs a result of the impact of the pandemic on patient enrollment, we now expect to complete the interim analysis in our URIROX-2 trial during the second or third quarter of 2022. Despite the challenges presented by the pandemic, we are grateful for the continued commitment and enthusiasm of our clinical investigators and patients, and are encouraged that both site initiation and recruitment have accelerated significantly in the early months of 2021. With the recent additions to our management team and the available proceeds from financing activities, we are operating from a position of strength, and look forward to delivering reloxaliase as the first potential treatment for patients with enteric hyperoxaluria and advancing ALLN-346 as a potential novel oral agent to treat patients with gout and chronic kidney disease (CKD).\u201d<\/p>\n

\n Clinical-Stage Product Candidate Updates<\/strong>\n <\/p>\n

\n Reloxaliase:<\/strong>
\n Novel oral biologic for enteric hyperoxaluria<\/strong>\n <\/p>\n

Reloxaliase is a first-in-class, non-absorbed, orally administered enzyme for the treatment of enteric hyperoxaluria. Reloxaliase exerts its effect by breaking down oxalate in the gastrointestinal (GI) tract, reducing the absorption of dietary oxalate. 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 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 potential accelerated approval, patients will also continue to be followed for a minimum of two years to confirm clinical benefit, including the ability of reloxaliase to reduce the incidence and severity of kidney stone disease and renal impairment. There are currently no approved treatments for enteric hyperoxaluria.<\/p>\n

\n ALLN-346: Novel oral biologic for hyperuricemia and gout<\/strong>\n <\/p>\n

ALLN-346 is a first-in-class, non-absorbed, orally administered enzyme for the treatment of hyperuricemia and gout. ALLN-346 is designed to exert its effect by breaking down urate in the GI tract, which is expected to lead to a concomitant reduction in urine and serum urate levels. Allena recently completed a Phase 1 single ascending dose study of ALLN-346 in healthy volunteers, which demonstrated no safety or tolerability concerns. In addition, an immunoassay of plasma samples demonstrated that ALLN-346 was not absorbed systemically. A Phase 1 multiple ascending dose study is expected to initiate in the second quarter of 2021, with initial results expected in the third quarter. Additionally, pending feedback from the FDA, a Phase 2a program in patients with hyperuricemia is planned for the second half of 2021, with initial efficacy data expected during the fourth quarter. The Company intends to focus its development program for ALLN-346 on the significant population of patients with hyperuricemia and gout who also suffer from CKD, for whom many of the current therapeutics are either dose-limited or contraindicated due to safety and tolerability concerns.<\/p>\n

\n Corporate Update<\/strong>\n <\/p>\n

\n Appointment of David Clark, M.D., M.R.C.P. as Chief Medical Officer<\/strong>\n <\/p>\n

In December 2020, Allena announced the appointment of David J. Clark, M.D., M.R.C.P. as Chief Medical Officer. Dr. Clark brings more than 20 years of industry experience to the Company, and has led development programs across multiple therapeutic categories, with an emphasis on immune-mediated and rare diseases. Dr. Clark earned his medical degree from the\u00a0University of Edinburgh Medical School and conducted a research fellowship in respiratory medicine at the\u00a0University of Dundee.<\/p>\n

\n Appointment of Richard Katz, M.D. as Chief Financial Officer<\/strong>\n <\/p>\n

In February 2021, Allena announced the appointment of Richard D. Katz, M.D. as Chief Financial Officer. Dr. Katz also brings more than 20 years of industry experience to the Company, having served as the chief financial officer for several biopharmaceutical companies after beginning his career in the Healthcare Group at Goldman, Sachs & Company. Dr. Katz earned his AB degree from Harvard University, his medical degree from the\u00a0Stanford University School of Medicine and his MBA from Harvard Business School. Dr. Katz has succeeded Edward Wholihan, whose planned departure was previously announced.<\/p>\n

\n Fourth Quarter 2020 Financial Results<\/strong>\n <\/p>\n