Elcelyx Therapeutics Completes Enrollment in Phase 2b Clinical Trial of Metformin Delayed Release for Type 2 Diabetes

SAN DIEGO, May 25, 2016 — Elcelyx Therapeutics announced today that it has completed enrollment of its Phase 2b clinical trial to evaluate Metformin Delayed Release (DR) in subjects with type 2 diabetes. The primary endpoint of this dose-ranging study is change in HbA1c from baseline at 16 weeks compared with placebo. The trial results are expected in the fourth quarter of this year and will serve to further document metformin’s gut mediated site of action and confirm doses to be studied in Phase 3 in patients with advanced renal disease. These data will complement results from Elcelyx’s previous Phase 2 clinical trial that showed reductions in fasting plasma glucose over 12 weeks with Metformin DR compared with placebo.

“We are eager to confirm and extend our previous findings that Metformin DR can achieve significant glucose control while minimizing systemic exposure at metformin doses that would be subtherapeutic or suboptimal using current formulations. This would support late-stage trials of Metformin DR in patients with type 2 diabetes and advanced renal disease, an under-served population that is either contraindicated from using currently available metformin or can only take a suboptimal dose due to the risk of life-threatening metformin-associated lactic acidosis,” said Alain Baron, M.D., president and chief executive officer of Elcelyx. “We believe Metformin DR can fulfill a valuable therapeutic role and allow continued use of metformin as first-line and foundational therapy in patients with type 2 diabetes along the continuum of renal impairment.”

Although metformin is the preferred agent for the treatment of type 2 diabetes, patients often discontinue it due to renal impairment and gastrointestinal intolerance. Physicians face numerous challenges with metformin use in patients with renal disease including the need to monitor renal function status to ensure appropriate use. Insulin, which has unique challenges from a patient management and safety perspective, is often the only treatment option available for these patients. The multicenter, randomized, Phase 2b dose-ranging study enrolled 571 subjects and is evaluating the glycemic effects of several doses Metformin DR (600, 900, 1200 and 1500 milligrams, once daily) compared with placebo in subjects with type 2 diabetes. The study also includes a single-blind comparator arm of subjects receiving 2000 milligrams of Metformin Immediate Release (IR) per day, administered as equally divided doses (1000 milligrams of metformin IR twice daily). In addition to measuring HbA1c over 16 weeks, safety and tolerability will be evaluated.

About Metformin DR
Metformin DR is an investigational product designed to target metformin delivery to the lower small intestine, where it is minimally absorbed yet elicits its full glucose lowering effect. 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 a 40 percent increase in apparent potency compared with Metformin XR and 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 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 www.elcelyx.com.

Karen Basbaum, Elcelyx Therapeutics
Senior Director, Business Development
(858) 876-1814 ext. 109

Pam Lord, Canale Communications
(619) 849-6003