View source version on https://anjipharma.com/news/anji-pharma-provides-update-on-anj900-pivotal-program/

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02 Jun 2022

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– Completed pharmacokinetic study of ANJ900 in healthy Chinese volunteers

– Data enables synchronous development of ANJ900 for type 2 diabetes (T2D) patients with chronic kidney disease (CKD) in U.S. and China

– Phase 3 initiation to support label expansion in T2D patients with advanced CKD anticipated in Q4 2022

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CAMBRIDGE, Mass. – June 2, 2022 – Anji Pharma, an emerging global medicines company, today announced successful completion of a pharmacokinetic (PK) study of ANJ900 in healthy Chinese volunteers to enable initiation of a pivotal clinical program in China later this year. ANJ900, a delayed-release formulation of metformin, is currently being studied in an ongoing multinational Phase 3 trial, DREAM-T2D, in type 2 diabetes (T2D) patients with normal, mild, and moderate chronic kidney disease (CKD stages 1-3B).

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“Data from this study are consistent with the pharmacokinetic, safety, and tolerability data already established for ANJ900 in Western populations,” said Dan Meyers, M.D., Chief Medical Officer at Anji. “The absence of food effect and significantly lower levels of metformin in plasma support our dose selection as we ready our pivotal program in China. We look forward to expanding our global ANJ900 Phase 3 program and bringing this important treatment option to T2D patients with all forms of CKD.”

“This confirmatory PK study was completed in a matter of weeks, highlighting the opportunity to accelerate clinical development in important markets like China,” noted Greg Dombal, Global Head of Development at Anji. “Based on our extensive interactions with the regulatory agency in China, we are confident that our plans to synchronously develop ANJ900 for T2D/CKD patients in the U.S., China, and other regions of the world remain on track.”

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The company plans to initiate a global Phase 3 trial, DREAM-CKD, to evaluate ANJ900 in T2D patients with advanced CKD (stage 3B and 4) in Q4 2022.

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About ANJ900

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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.

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About DREAM-T2D

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The ongoing trial is a Phase 3 randomized, multicenter, double-blind, parallel-group, placebo and comparator-controlled study to compare the glycemic effects, safety and tolerability of ANJ900 tablets in patients with T2D with varying renal function from normal up to CKD 3B. Approximately 675 patients will be randomly assigned to 1 of 3 treatment groups. The study will assess change in HbA1c through 28 weeks for ANJ900 compared to placebo as a primary endpoint. In addition, assessments of change in HbA1c for ANJ900 compared to Metformin IR and assessment of absolute change in HbA1c will be evaluated in the study. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04854512)

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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 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.

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