Metformin DR (metformin delayed-release) is Elcelyx’s lead product candidate, currently in Phase 2b development as a potential agent uniquely suited for patients who cannot currently use metformin owing to contraindications or poor tolerability.

Elcelyx retains full worldwide rights to the Metformin DR program.

Unmet Needs in type 2 diabetes

According to the National Diabetes Statistic Report published in 2014, 9.3% of the U.S. population has diabetes, representing over 29 million Americans. Diabetes remains the 7th leading cause of death in the United States and is the biggest single contributor to several co-morbidities including kidney disease and limb amputation.

“Metformin, if not contraindicated and if tolerated,
is preferred initial pharmacological agent for type 2 diabetes”
– 2013 ADA Position Statement

Despite the position from world associations and leading experts in the field that metformin is the preferred initial agent for the treatment of type 2 diabetes, market research has demonstrated that approximately 40% of the 18 million treated patients in the United States are not benefiting from metformin therapy. The two most common reasons cited by physicians are:

  1. Contraindication due to renal impairment
  2. Gastro-intestinal (GI) intolerance that leads to discontinuation or dose reduction