CAMBRIDGE, Messe & SHANGHAI – (BUSINESS WIRE) – Anji Pharma (“Anji”) has initiated a pivotal study of ANJ900 (sustained-release metformin) in patients with type 2 diabetes (T2D), including patients with various stages of kidney disease. As part of Anji’s global clinical trial program called “DREAM-T2D”, patients with T2D with normal kidney function through to stage 3B chronic kidney disease (CKD) will be enrolled in the study for up to 52 weeks and on HbA1c throughout the treatment period -Values examined assessed.
Although metformin is the mainstay of oral T2D therapy, it is contraindicated in T2D patients with advanced CKD due to a rare but potentially life-threatening side effect called lactic acidosis. Without metformin, T2D patients with advanced CKD often require high doses of insulin to achieve glucose control, which can increase the risk of severe hypoglycemia. Based on the latest findings that the glucose-lowering effects of metformin are largely attributed to its direct action on the intestinal wall, Anji is developing an intestinal-targeted metformin for use in T2D patients with kidney disease.
Anji’s DREAM-T2D study includes clinical centers in North America, Europe, Asia, and Latin America. With the introduction of DREAM-T2D, Anji operationalized its “hub-and-spoke” model to integrate clinical, regulatory and manufacturing expertise while partnering closely with the drug development business of Labcorp, a leading global life cycle company. Science companies to reach an order of magnitude.
“The successful launch of an international, multi-center, pivotal study amid a global pandemic is a tremendous achievement for both the Anji and Covance by Labcorp teams,” said Greg Dombal, Global Head of Development at Anji. “We are happy that Covance by Labcorp embodies several of Anji’s core values - being good partners and acting urgently – so that we can deliver medicines quickly to patients around the world.”
“Improving the lives of diabetics with kidney disease is more than a commendable goal, it is an achievable goal,” said Honggang Bi, Ph.D., senior vice president and head of APAC, Covance by Labcorp. “This new partnership underscores our commitment to patients with T2D and CKD and is a significant step forward in their struggle.”
Labcorp’s Covance has long played an important role in clinical diabetes and endocrinology research and drug development. Through its team of subject matter experts, the company offers fast, intelligent solutions that optimize results and drive scientific progress. In June, Covance by Labcorp will also be known under the Labcorp Drug Development brand.
Anji plans to expand the ANJ900 study to more severe CKD populations (including CKD4) in a separate Phase 3 study called DREAM-CKD.
About Anji Pharma
Anji Pharma is a clinical stage company committed to delivering life changing therapies to patients as efficiently as possible. Anji’s asset-centric business model enables speed and flexibility in increasing value and utilizes a clinical and regulatory core that operates with “hub-and-spoke” efficiency. Anji’s clinical pipeline is sustained release metformin (ANJ900 – Ph3) for effective glucose management in patients with type 2 diabetes and advanced chronic kidney disease, followed by pradigastat (ANJ908 – Ph2) for the treatment of chronic constipation. For more information, please visit www .anjipharma.com.
