Anji Pharmaceuticals Acquires Late-Stage Clinical Asset and Readies for Ph3 Trials in Type 2 Diabetes with Chronic Kidney Disease

CAMBRIDGE, Mass. — Anji Pharmaceuticals, Inc. (“Anji” or “the Company”) today announced the acquisition of global development rights for a novel delayed-release formulation of metformin (Metformin DR). Originally developed by Elcelyx Therapeutics, Metformin DR is an investigational product designed to target metformin delivery to the lower small intestine. In a recent Phase 2b study with 571 enrolled subjects, Metformin DR afforded robust glucose lowering with significantly reduced systemic exposure, demonstrating a tolerability profile potentially suitable for type 2 diabetes patients who are currently restricted or contraindicated to metformin use (due to impaired renal function) or those with poor tolerance to other metformin regimens. Having received input from the FDA on its clinical development plan, Anji plans to initiate a pivotal Phase 3 study in patients with Chronic Kidney Disease (Stage 3b/4) later this year.

“We are extremely excited to add Metformin DR to our late-stage clinical pipeline,” noted Dr. Dan Meyers, Chief Medical Officer of Anji. “We recognize the importance of new treatment options for patients with type 2 diabetes with advanced kidney disease who cannot take metformin due to risk of lactic acidosis. Metformin DR has the potential to give CKD patients access to a first-line therapy that has been the mainstay for decades.”

“We are very pleased to see the continued progression of Metformin DR through our partnership with Anji,” comments Alain Baron, MD, president and Chief Executive Officer of Elcelyx. “Finding a science-driven organization that recognized the tremendous potential of gut-specific delivery of metformin was crucial to our program strategy. We are excited to work with Anji on the Ph3 global program of Metformin DR and accelerate its availability to patients in need of better glycemic control.”

About Metformin DR

Metformin DR has been studied in nine previous clinical trials including an earlier Phase 2 study where various doses of Metformin DR were compared with placebo or Metformin Extended Release (XR) in subjects with type 2 diabetes. In that study, Metformin DR exhibited statistically significant and sustained reductions in fasting plasma glucose over 12 weeks compared with placebo. Metformin DR was well tolerated at all doses tested.

About Anji Pharmaceuticals

With its platform of using human genetic data to drive target selection, Anji has built a robust pipeline of clinical assets to treat cardiometabolic disorders. Anji has recruited a nimble and experienced clinical team to advance novel treatment paradigms, especially in the areas of gut and lipid metabolism. Anji’s pipeline reflects their strategy to rapidly bring life-changing therapies to patients and synchronize the clinical development of innovative medicines across the world.

About Elcelyx Therapeutics

Elcelyx Therapeutics is developing pharmaceutical agents designed to modulate the gut neuroendocrine system including the L-cell, which when activated is responsible for release of glucoregulatory hormones. Metformin Delayed Release (Metformin DR), the first product of this type, is designed to deliver metformin to the gut instead of systemically, thereby reducing bioavailability while still achieving efficacy. Metformin DR development arose from Elcelyx’s discovery that the site of action for metformin, the most commonly prescribed diabetes drug, is in the gut. Given its targeted delivery and low systemic bioavailability, Metformin DR may provide a treatment option for type 2 diabetes patients who are currently contraindicated due to renal impairment or who cannot tolerate existing metformin formulations. For more information, visit elcelyx.com.

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