【Portfolio】Anji Pharma Provides Update on Two Lead Programs
Source from Anji Pharma
23 Jun 2022
- Completed enrollment for Phase 2 study of ANJ908 in chronic idiopathic constipation
- Enrolling type 2 diabetes (T2D) patients with normal to moderate chronic kidney disease (CKD stages 1-3B) in global Phase 3 study of ANJ900
- Planning Q4 2022 expansion of ANJ900 into T2D patients with CKD 3B/4
At Anji Pharma, we have exciting updates on our two lead clinical programs, ANJ908 and ANJ900. We shared progress on these programs at two prominent scientific conferences: Digestive Disease Week (DDW) from May 21-24 in San Diego and the American Diabetes Association (ADA) 82nd Scientific Sessions from June 3-7 in New Orleans. ANJ908 and ANJ900 have the potential to unlock significant value in Anji’s clinical pipeline and fulfill our mission of improving lives globally.
Anji @ DDW 2022
ANJ908 is an inhibitor of diacylglycerol acyltransferase 1 (DGAT1), an enzyme which facilitates re-assembly of meal triglycerides and acts as a sensor of dietary fat intake. Inhibition of DGAT1 is a novel mechanism of action to treat chronic constipation and has the potential to offer significantly greater response rates to patients compared to current treatment options. At this year's DDW, Dan Meyers, Alice McElhinney, and Tammy Pasqualini represented Team Anji and assembled the ANJ908 clinical advisory board to review preliminary Phase 2 data and discuss potential registration strategies. The trial was conducted in five clinical sites in the U.S. and 20 clinical sites in China, and we plan to report topline data from this study in the coming months.
A big shout-out to the ANJ908 program team, including May Li, Ming Yang, and Greg Dombal, for their dedication and hard work; performing the bulk of a multinational Phase 2 study during a global pandemic is no small feat!
Anji @ ADA 2022
Members of the ANJ900 project team at the ADA 82nd Scientific Sessions
ANJ900 is a metformin-based treatment for patients with T2D and CKD. Metformin is the most widely prescribed drug for the treatment of T2D; however, it is contraindicated in a large and growing subset of diabetic patients who also have CKD. Our Phase 3 trial in T2D patients with CKD 1-3B, called DREAM-T2D, is ongoing in 7 countries across North America, Europe, and South America.
Plans are underway to expand access of ANJ900 to patients with more advanced forms of CKD. Towards this goal, the team has reached two important milestones: 1) the regulatory alignment in both the U.S. and China on the study design for advanced CKD patients; and 2) the completion of a pharmacokinetic study in healthy Chinese volunteers to enable initiation of label expansion studies in the U.S., China, and other major markets later this year.
Bravo to Sandy Hurd, Shary Lavoie, and the rest of the ANJ900 program team for achieving these important milestones.
To share the ANJ900 program with the broader community, we produced this informational video which describes how metformin and ANJ900 work to lower glucose in T2D patients.
We’ve also summarized all the recent mechanistic data on metformin in this white paper. Thanks to Virendar Kaushik, Mike Serrano-Wu, and Dan Meyers for putting out this white paper.
Next Steps for Anji
It’s a busy summer ahead for the Anji-verse as we finalize a clinical study report for the ANJ908 Phase 2 trial and begin preparations for Phase 3. Preparations for the next ANJ900 pivotal trials are also well underway. Our team has grown, and we’re working hard to scale our organization while staying nimble. Stay tuned for more updates and please reach out to the team with any questions!
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 distributed hub-and-spoke model for synchronous clinical development in multiple regions of the globe. 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, and pradigastat (ANJ908 in Phase 2) for treatment of chronic idiopathic constipation. Anji’s early-stage pipeline features additional assets which are poised to enter clinical studies in the next 18 months. Learn more about the Anji-verse here: https://anjipharma.com/about/our-team/.