【Portfolio】Anji Pharma Fully Enrolls Cohort at Leading Beijing Hospital to Ready Global ANJ900 Pivotal Program in Asia
View source version on https://anjipharma.com/news/anji-pharma-fully-enrolls-cohort-at-leading-beijing-hospital-to-ready-global-anj900-pivotal-program-in-asia/
Two weeks from site initiation to full enrollment highlights strategic upside of Anji’s China-inclusive clinical development
Data to support NDA submission in all major chronic kidney disease (CKD) markets within 1-2 years of U.S. filing
Phase 3 program (DREAM-T2D) will include 12 countries with topline data expected in 2023
CAMBRIDGE, Mass., and SHANGHAI, November 30, 2021 — Anji Pharma (“Anji”), an emerging global medicines company, today announced full enrollment for a confirmatory study in Chinese healthy participants for a delayed-release formulation of metformin called ANJ900. The Beijing study will determine whether ANJ900 can deliver metformin without exceeding the threshold of safe metformin exposure in plasma, which potentially could provide millions of chronic kidney patients with Type 2 diabetes (CKD/T2D) a treatment option where metformin is currently contraindicated. Anji plans to report topline data from this study in January 2022.
“The full enrollment of the Beijing study is an important milestone for our DREAM-T2D program and our multi-national clinical operations organization,” noted Greg Dombal, Anji’s Global Head of Development. “CKD/T2D patients need safer alternatives to insulin, and Anji is determined to bring important medicines like ANJ900 to patients in all areas of the globe as fast as possible.”
ANJ900 is designed to deliver metformin specifically to the gut and is under investigation in T2D patients with moderate renal impairment (the “DREAM-T2D” trial, NCT04854512). Recent publications highlight the major role of the gut in metformin-induced glucose disposal, akin to how other T2D medications, such as SGLT2 inhibitors, promote glucose excretion via the kidney. Since the U.S. initiation of DREAM-T2D trials in June, Anji has submitted regulatory filings in 11 other health authorities across North America, Europe, Asia, and Latin America.
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 clinical and regulatory core that operates with “hub-and-spoke" efficiency. Anji’s clinical pipeline includes gut-targeted metformin (ANJ900 in Phase 3) intended for glucose management in patients with type 2 diabetes and advanced chronic kidney disease, as well as pradigastat (ANJ908 in Phase 2) for treatment of functional constipation. For more info, visit www.anjipharma.com.