Pipeline
A new approach to treating patients with metabolic diseases

Allena Pipeline hero- Employee in the lab

Our Oral Biologic Platform

We are committed to leveraging our expertise in oral enzymes to develop first-of-its-kind targeted therapies that work within the gastrointestinal (GI) tract to limit the downstream effects of metabolic diseases, including kidney stones, gout, and chronic kidney disease.

Click on a program to learn more about what’s in our pipeline

Reloxaliase Enteric hyperoxaluria Worldwide Systemic oxalosis Worldwide Primary hyperoxaluria (orphan designation) Worldwide Pediatric hyperoxaluria (orphan designation) Worldwide ALLN-346 Hyperuricemia, Gout, and Chronic kidney disease Worldwide

Reloxaliase

Reloxaliase molecules

Reloxaliase is a first-in-class, orally administered, non-absorbed enzyme for the treatment of hyperoxaluria. Its formulation was designed to degrade oxalate within the GI tract and limit the systemic absorption of oxalate into the bloodstream. A decrease in systemic absorption of oxalate reduces the burden on the kidney, ultimately reducing the risk of kidney stones and other serious kidney diseases. Clinical trials in healthy volunteers and patients with enteric hyperoxaluria demonstrated that reloxaliase:

  • Substantially reduced urinary oxalate excretion in patients with enteric hyperoxaluria
  • Was well tolerated, with no drug-related serious or severe adverse events
  • Specifically targets oxalate, with minimal to no changes in other urine parameters

We are initially developing reloxaliase for adult patients with enteric hyperoxaluria (a form of the disease that is the result of certain GI disorders that cause fat malabsorption such as Crohn’s disease and complications from bariatric surgery). If approved, it has the potential to help treat 200,000 to 250,000 patients with enteric hyperoxaluria in the US alone. The urirox1 phase3 trial in patients with enteric hyperoxaluria met primary endpoint and second phase 3 trial urirox2 is ongoing.

The FDA has also granted separate orphan drug designations to reloxaliase for the treatment of primary hyperoxaluria (a form of the disease that results from a rare genetic disorder) and for the treatment of pediatric hyperoxaluria.

We have an ongoing phase 3 clinical trial that is actively recruiting patients with enteric hyperoxaluria.

ALLN-346

ALLN-346 Molecules

ALLN-346 is a first-in-class orally administered non-absorbed enzyme that breaks down urate in the GI tract. It has the potential to treat hyperuricemia and lower the risk of urate-related complications, including gouty flares, arthritis, and urate-based stones in the kidney, bladder, or urinary tract. If approved, ALLN-346 may be used to help treat approximately 375,000 patients living with uncontrolled gout and related advanced CKD.

We are initially targeting ALLN-346 for patients with hyperuricemia and gout who have moderate to severe CKD.

Oral Biologic Platform

We are working to expand our pipeline of first-in-class oral enzyme therapeutic candidates to treat patients with rare and severe metabolic disorders.

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Jerome Gangitano

Vice President of Manufacturing and Process Development

Jerome Gangitano is the Vice President of Manufacturing and Process Development at Allena Pharmaceuticals. He is an experienced operations executive with more than 30 years of experience in the pharmaceutical and device industries. He has developed, commercialized, and supplied numerous products.

Prior to joining Allena, Jerome was a Site Head at Sanofi where he led a site including Safety and Environmental, Quality, Manufacturing, Process Development – MSAT; Facilities-Engineering, Supply Chain, Materials Purchasing, and Operational Excellence. Prior to his time at Sanofi, Jerome held various leadership positions in Operations, Manufacturing, and Quality at Genzyme, Focal, Johnson & Johnson, and Multiple Peptide Systems. Jerome received his BS in Chemistry from San Diego State University.

Kevin Brennan

Vice President, Finance

Kevin Brennan is the Vice President Finance at Allena Pharmaceuticals. Kevin joined the Allena team in 2011 as the Associate Director, Finance and has played an integral role in financial strategy, planning and operations, and the development and monitoring of systems designed to manage the organization’s finance and reporting. Kevin brings over twenty years of experience in the life science industry. Prior to joining Allena, Kevin held various positions at Alnara Pharmaceuticals, Altus Pharmaceuticals, and Genzyme, where he worked cross-functionally to drive strategic initiatives and optimize planning and reporting processes.

Kevin holds a B.S. in Accounting from Boston College.

Stephen Yu

Senior Vice President, Corporate Quality

Stephen Yu is Senior Vice President of Corporate Quality at Allena Pharmaceuticals. Stephen provides leadership for the internal Quality Assurance and Quality Control functions and oversight across internal and external GxP activities for Allena’s programs and facilities.

Stephen brings over 40 years of drug development and commercialization experience in technical and quality compliance roles. Over the past year, he has worked as Senior Vice President of Quality at Lyndra Therapeutics, a private company based in Watertown. In addition to serving previously as Vice President of Quality Assurance at Allena, Stephen has led his self-directed consultancy, Sky Pharma Consulting, and held prior roles as Vice President of Corporate Quality at Immunogen, as well as roles in Quality and Manufacturing at Genzyme, Merck & Co and Schering-Plough Research Institute.

Stephen earned a B.S. in Chemical Engineering from M.I.T. and an M.B.A. from Rutgers University.

Richard Katz, M.D.

Chief Financial Officer

Richard Katz, M.D. has served as chief financial officer since January 2021. Richard brings to Allena more than 20 years of experience in healthcare finance and corporate development.

Prior to joining Allena, Richard served as the chief financial officer of several biopharmaceutical companies, including Liquidia Technologies, Argos Therapeutics, Viamet Pharmaceuticals and Icagen, Inc. At Icagen, he played an instrumental role in the company’s initial public offering and subsequent financings, the formation of several strategic collaborations and the company’s sale to Pfizer. Richard began his career as a vice president in the healthcare investment banking group at Goldman, Sachs & Company, where he executed a broad range of transactions, including equity and debt financings, mergers and acquisitions, and corporate restructurings.

He holds a B.A. in applied mathematics from Harvard University, an M.D. from the Stanford University School of Medicine and an M.B.A. from Harvard Business School.

Alicja Januszewicz, PhD.

Vice President, People & Culture

Alicja Januszewicz, Ph.D., has served as the Head of People & Culture since 2019. Before joining Allena, she consulted with small organizations in Cambridge within talent management: employee development, organizational development, succession management, high potentials, and workforce planning. Previously, she had served as the Head of Talent Management at Baxalta Innovation Center, where she supported global R&D teams until the Shire acquisition.

Prior to joining Baxalta, Alicja served as Head of Talent Management at Epizyme and Boston Scientific HQ. She also supported the organizational development of Genzyme’s global HR manufacturing group.

Alicja holds a Ph.D. in Sociology from the Polish Academy of Science. She is a graduate of the Talent Management Institute, University of North Carolina, Kenan-Flagler Business School.

David J. Clark, M.D.

Chief Medical Officer

David J. Clark, M.D. has served as Chief Medical Officer since November 2020. He has over 20 years of global industry experience in biopharmaceutical companies based in the United States and Europe.

Before joining Allena, David served as the Chief Medical Officer of Aldeyra Therapeutics, a publicly-traded biotechnology company developing medicines for immune-mediated ocular and systemic diseases. He also served as Chief Medical Officer of Wilson Therapeutics, a privately-held biotechnology company developing novel pharmaceuticals to treat Wilson Disease, a rare autosomal recessive disorder of copper metabolism. David further served as Chief Medical Officer at NormOxys Inc. and TransTech Pharma, LLC. He has held leadership positions at a range of pharmaceutical companies including Pfizer, GlaxoSmithKline, and SmithKline Beecham.

David received his medical degree from the University of Edinburgh, trained in internal medicine, and conducted respiratory medicine academic research.

Geoffrey Swire

Acting Chief Operating Officer and Senior Vice President, Corporate Development

Geoffrey Swire joined Allena in 2018 and currently serves as Acting Chief Operating Officer and Senior Vice President, Corporate Development. Geoffrey has 20 years of leadership experience in business, product, and commercial development for life sciences companies.
 
Geoff previously worked at Radius Health, where he served as head of business development and alliance management, and earlier as program leader for the global Phase 3 osteoporosis development program. Prior to that, Geoff spent seven years at Genzyme, where he held various leadership positions in the Transplant and  Oncology business units, including as head of program and portfolio management, as well as vice president of global commercial operations. Geoff played a central role in the acquisition, development, regulatory approvals, and global commercial launch of Mozobil for patients undergoing stem cell transplants. He started his career in strategy and product development consulting at Integral, Inc., and Accenture’s Health & Life Sciences practice.

Geoff holds a B.A. in French and History from Dartmouth College and a Master’s in Public Policy from Harvard University

Hugh Wight

Senior Vice President, Technical Operations

Hugh Wight is senior vice president of technical operations at Allena Pharmaceuticals. He is an experienced manufacturing executive with more than 20 years in pharmaceutical and biopharmaceutical development, manufacturing, validation and quality assurance.

Prior to joining Allena, Hugh was vice president, technical operations for Alnara Pharmaceuticals, where he led manufacturing, project management, quality assurance and control, and fostered strategic partnerships with manufacturing organizations. Prior to his time at Alnara, Hugh held various quality assurance and validation leadership positions at Altus Pharmaceuticals, Alkermes, Aquila Biopharmaceuticals, AutoImmune and InSite Vision.

Hugh holds a B.S. in microbiology from the University of Maine-Orono.

Louis Brenner, MD

President and Chief Executive Officer

Lou Brenner, MD, has served as chief executive officer of Allena since February 2019 and as president since February 2017. He previously served as chief operating officer from April 2015 to January 2019.

Lou has more than a decade of industry leadership experience, including pharmaceutical development strategy, regulatory affairs, business development, and commercialization. Prior to joining Allena, Lou served as chief medical officer at Idera Pharmaceuticals, chief medical officer at Radius Health, and senior vice president at AMAG Pharmaceuticals. He began his industry career at Genzyme Corporation, where he led successful product development programs for medicines that are currently marketed in the renal and metabolic areas.

He holds an MD from Duke University, an MBA from Harvard Business School, and a BS from Yale University, He completed his residency in internal medicine at Brigham and Women’s Hospital and his fellowship in nephrology at Brigham and Women’s Hospital and Massachusetts General Hospital. Lou holds a clinical appointment at Brigham and Women’s Hospital.