View source version on https://anjipharma.com/news/anji-pharma-adds-clinical-sites-to-accelerate-clinical-development-of-pradigastat-for-the-treatment-of-functional-constipation/

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15 Apr 2021

A “Truly Global” Development Strategy Keeps Phase 2 Program on Track Amidst Worldwide Pandemic

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CAMBRIDGE, Mass. and SHANGHAI – Anji Pharma has initiated dosing in the U.S. and China as part of a Phase 2 program for pradigastat (ANJ908) in functional constipation. Pradigastat, a first-in-class inhibitor of diacylglycerol acyl transferase 1 (DGAT1), has a robust safety and pharmacodynamic profile that has been rigorously established across multiple clinical studies.

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Chronic constipation affects nearly one in seven Americans, with nearly two million patients seeking pharmacotherapy options worldwide. In addition to functional constipation, related conditions where pradigastat may have clinical benefit include irritable bowel syndrome-associated and opioid-induced constipation.

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“Despite the prevalence of chronic constipation, current treatment options are desperately lacking, with low response rates typical for all approved medications,” said Dan Meyers, M.D., Chief Medical Officer of Anji. “Based on our analysis of existing clinical data, we anticipate pradigastat will offer patients and physicians a significantly higher response rate, and we look forward to sharing the data as it becomes available.”

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To accelerate bringing medicines to patients across the globe, Anji has synchronized development in North America and Asia to allow new drug application (NDA) filings in near-simultaneous fashion across major markets. Anji’s Phase 2 study with pradigastat will enroll approximately 180 patients at clinical sites in U.S. and China. Patients will receive pradigastat tablets (20 or 40 mg) or placebo once daily for four weeks and evaluated for improvements in constipation measures (ClinicalTrials.gov Identifier NCT04620161).

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Anji holds pradigastat development and commercial rights for constipation-related disorders in all global markets, including U.S., Europe, and Asia.

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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.  Taking inspiration from its namesake bridge in Hebei Province, Anji strives to “Aid Those in Need,” while building connectivity across patient-centric ecosystems.  In addition to pradigastat, Anji is developing delayed-release metformin (ANJ900) for effective glucose management in patients with type 2 diabetes and advanced chronic kidney disease.  Global pivotal trials for ANJ900 are expected to initiate by mid-2021.

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