View source version on https://anjipharma.com/news/anji-pharma-launches-phase-3-trial-for-anj900-to-treat-type-2-diabetes-patients-with-kidney-disease/

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10 Jun 2021

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Gut-targeted metformin is expected to lower blood glucose but limit systemic drug levels, opening treatment options for T2D patients with renal insufficiency

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CAMBRIDGE, Mass. and SHANGHAI, JUNE 10, 2021 — Anji Pharma (“Anji”) has initiated a pivotal trial of ANJ900 (delayed-release metformin) in patients with Type 2 diabetes (T2D), including those with varying stages of renal disease. As part of Anji’s global clinical study program, called “DREAM-T2D,” patients with T2D having normal kidney function to Stage 3B chronic kidney disease (CKD) will be enrolled for as long as 52 weeks and assessed for HbA1c levels throughout the treatment period.

Despite being the mainstay of oral T2D therapy, metformin 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 recent evidence that metformin’s glucose-lowering effects are largely attributed to direct action at the gut wall, Anji is developing a gut-targeted metformin for use in T2D patients with kidney disease.

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Anji’s DREAM-T2D study includes clinical sites in North America, Europe, Asia, and Latin America. In launching DREAM-T2D, Anji has operationalized its “hub-and-spoke” model to insource core clinical, regulatory, and manufacturing expertise whilst achieving scale through close partnership with the drug development business of Labcorp, a leading global life sciences company.

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“Successfully launching an international, multi-center, pivotal trial amidst a global pandemic is a tremendous accomplishment for both the Anji and Covance by Labcorp teams,” noted Greg Dombal, Global Head of Development at Anji. “We feel fortunate that Covance by Labcorp embodies several core Anji values—be good partners and act with urgency—so that we may rapidly deliver medicine to patients across the globe.”

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“Improving the lives of diabetics with renal disease is more than just a laudable goal, it’s an achievable one,” said Honggang Bi, Ph.D., Senior Vice President and Head of APAC at Covance by Labcorp. “This new partnership underscores our commitment to patients with T2D and CKD and marks a meaningful step forward in their fight.”

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Covance by Labcorp has long played an important role in diabetes and endocrinology clinical research and drug development. Through its team of subject matter experts, the company provides fast, intelligent solutions that optimize results and drive scientific advancements. In June, Covance by Labcorp will also be known under the brand Labcorp Drug Development.

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Anji plans to expand investigation of ANJ900 into more severe CKD populations (including CKD4) in a separate Phase 3 trial called “DREAM-CKD.” 

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About Anji Pharma

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Anji Pharma is a clinical-stage company dedicated to bringing life-changing therapies to patients as efficiently as possible. Anji’s asset-centric business model allows for speed and flexibility in building value, leveraging a clinical and regulatory core that operates with “hub-and-spoke” efficiency. Anji’s clinical pipeline is led by delayed-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 treatment of chronic constipation.