Anji Pharma Announces Formation of Clinical Advisory Board for Lead Program ANJ900

World-class clinical and medical leaders to guide late-stage development of ANJ900 for type 2 diabetes (T2D) patients with chronic kidney disease (CKD)

CAMBRIDGE, Mass. – June 2, 2022 – Anji Pharma, an emerging global medicines company, today announced the formation of a clinical advisory board to support its lead program, ANJ900, a delayed-release formulation of metformin. ANJ900 is currently being studied in an ongoing global Phase 3 trial, DREAM-T2D, in T2D patients with moderate CKD (stages 1-3B).

“We’re excited to bring together a group of highly accomplished clinicians and researchers in the fields of diabetes and kidney disease to help guide the late-stage clinical development of ANJ900,” said Brian Hubbard, Ph.D., Chief Executive Officer of Anji. “As we advance ANJ900 through pivotal programs – DREAM-T2D for type 2 diabetes patients with mild CKD and DREAM-CKD for patients with more advanced CKD – their insights and contributions will be instrumental.”

“We look forward to working with this group of world-class experts to bring a new treatment option to patients with type 2 diabetes and chronic kidney disease,” said Dan Meyers, M.D., Chief Medical Officer of Anji. “Their deep knowledge of complex underlying disease processes coupled with a keen understanding of patient needs will contribute an immediate positive impact on our patient-oriented clinical development of ANJ900.”

The members of the clinical advisory board include:

• Clifford Bailey, Ph.D., FRCP (Edin) – Dr. Bailey is Professor of Clinical Science at Aston University (Birmingham, England). He is a Fellow of the Royal College of Physicians of Edinburgh and a Fellow of the Royal College of Pathologists. His research is focused on the pathogenesis and treatment of diabetes. In recognition of his research, Dr. Bailey received the Lunar Society medal and the Banting Lecture award.
• George Bakris, M.D. – Dr. Bakris is Director of the American Heart Association’s Comprehensive Hypertension Center at the University of Chicago Medicine. He specializes in the diagnosis and reduction of difficult to treat high blood pressure and in clinical trials involving diabetes-related kidney disease. Dr. Bakris has been extensively involved as principal investigator and steering committees of national and international trials involving diabetic kidney disease progression and resistant hypertension. Dr. Bakris received the Irvine Page-Alva Bradley Lifetime Achievement Award to acknowledge his lifetime of outstanding achievements in the field of hypertension.
• John Buse, M.D., Ph.D. – Dr. Buse is the Verne S. Caviness Distinguished Professor, Chief of the Division of Endocrinology, Director of the Diabetes Center, Director of the NC Translational and Clinical Sciences Institute and Senior Associate Dean for Clinical Research at the University of North Carolina (UNC) School of Medicine in Chapel Hill, North Carolina. Dr. Buse currently works with a team of investigators and study coordinators at UNC in the conduct of multicenter and single-site studies in the prevention and treatment of type 1 and 2 diabetes mellitus. Dr. Buse completed service as President for Medicine & Science at the American Diabetes Association (ADA) in 2008. He is the recipient of the 2010 Castle Connolly National Physician of the Year Award and the ADA Outstanding Achievement in Clinical Diabetes Research Award.
• Ralph DeFronzo, M.D. – Dr. DeFronzo is the Professor of Medicine and Chief of the Diabetes Division at the University of Texas Health Science Center and the Deputy Director of the Texas Diabetes Institute, San Antonio, Texas. He led the U.S. development of metformin, the first-line medication for treatment of diabetes, and ushered it through FDA approval in 1995. More recently, he discovered a new approach to diabetes treatment that targets glucose reabsorption in the kidneys. This work led to the development and approval of other widely used drugs, including dapagliflozin, empagliflozin, and canagliflozin. Dr. DeFronzo received the Banting Award from the ADA and the Claude Bernard Award from the European Association for the Study of Diabetes. He is also the recipient of the Harold Hamm International Prize for Biomedical Research in Diabetes.
• Rury Holman, FMedSci – Dr. Holman is Emeritus Professor of Diabetic Medicine at the University of Oxford, Emeritus Director of the University of Oxford Diabetes Trial Unit, and an Emeritus NIHR Senior Investigator. Dr. Holman has delivered landmark clinical outcome trials over the past four decades and is an exemplary clinical scientist and global leader in the field of diabetes. Among his major accomplishments is the co-design and operation of the 30-year UK Prospective Diabetes Study (UKPDS), which ushered in the modern era of diabetes risk factor management. Dr. Holman is the recipient of the Diabetes UK Banting Award and the ADA Outstanding Achievement in Clinical Diabetes Research Award.
• Steven Kahn, M.B., Ch.B. – Dr. Kahn is a Professor of Medicine in the Division of Metabolism, Endocrinology and Nutrition at the VA Puget Sound Health Care System and University of Washington in Seattle, Washington. He directs the Diabetes Research Center at the University of Washington. Dr. Kahn’s research interests include the role of β-cell in the pathogenesis and treatment of prediabetes and type 2 diabetes. He has received numerous awards for his research including the ADA Distinguished Clinical Scientist Award, Endocrine Society Clinical Investigator Award and Claude Bernard Award from the European Association for the Study of Diabetes.
• Matt Riddle, M.D. – Dr. Riddle is Professor of Medicine and Head of the Section of Diabetes in the Division of Endocrinology/Diabetes/Clinical Nutrition at Oregon Health Sciences University. For two decades he directed the Diabetes Center at Oregon Health & Science University. His interests include the pathophysiology and complications of type 1 and type 2 diabetes, basal insulin therapy, newer therapeutic agents, combination therapies, cardiovascular outcomes of diabetes, and the organization of care for diabetes. He has had leadership responsibilities in various large, multinational, medical outcome trials, and chairs the NIDDK’s Observational Study Monitoring Board for DCCT/EDIC. Currently he is Editor-in-Chief of Diabetes Care. He is the recipient of the ADA’s Outstanding Physician-Clinician Award.

About ANJ900

ANJ900 is a gut-targeted formulation designed to lower glucose with reduced systemic exposure of metformin, so that patients who cannot take currently available formulations of metformin may achieve better glucose control. ANJ900 leverages recent insight that a primary site of action of metformin, a mainstay of oral T2D therapy, is the region of cells lining the gut wall. More information about the gut effects of metformin can be found in this video and article.

About Anji Pharma

Anji Pharma is a clinical-stage company dedicated to bringing life-changing therapies to patients across the globe. Anji’s asset-centric business model allows for speed and flexibility in building value, leveraging a distributed hub-and-spoke model for synchronous clinical development. In addition to ANJ900, Anji’s clinical pipeline includes pradigastat (ANJ908 in Phase 2) for treatment of chronic idiopathic constipation. For more info, visit www.anjipharma.com, follow us on social media – Twitter: @AnjiPharmaUS, LinkedIn: @Anji Pharma, and subscribe to our YouTube channel.

Contacts

Corporate Contact:
Michael Serrano-Wu, Ph.D.
[email protected]

Media Contact:
Emily Wong
MacDougall Advisors
[email protected]