Anji Pharmaceuticals Inc revealed on Wednesday that it has completed the acquisition of global development rights for a novel delayed-release formulation of metformin (Metformin DR) for an undisclosed amount.

Originally developed by Elcelyx Therapeutics, Metformin DR is an investigational product designed to target metformin delivery to the lower small intestine.

Under the Phase 2b study in 571 enrolled subjects, Elcelyx's Metformin DR afforded robust glucose lowering with reduced systemic exposure, demonstrating a tolerability profile suitable for type 2 diabetes patients who are currently restricted or contraindicated to metformin use or those with poor tolerance to other metformin regimens.

Following the acquisition and having received input from the US 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.

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. Metformin DR was well tolerated at all doses tested, concluded the company.