SAN DIEGO, Nov. 10, 2016 /PRNewswire/ -- Elcelyx Therapeutics announced today that its Phase 2b dose-ranging study met the primary endpoint of showing a statistically significant reduction in HbA1c at 16 weeks with Metformin Delayed Release (Metformin DR) compared with placebo in subjects with type 2 diabetes. Metformin DR is an investigational product designed to target metformin delivery to the lower small intestine, where it is minimally absorbed yet elicits robust glucose lowering effects. The study results support the further development of Metformin DR for type 2 diabetes patients with renal impairment in whom metformin use is contraindicated as well as those patients with gastrointestinal intolerance to current metformin formulations.
"Patients with type 2 diabetes whose advanced kidney disease prevents them from effectively clearing metformin from their circulation are at increased risk for potentially toxic metformin-associated lactic acidosis," said Robert Henry, M.D., professor of medicine at the University of California San Diego School of Medicine and chief, endocrinology & metabolism, VA San Diego Healthcare System. "Gut-mediated Metformin DR which has minimal absorption leading to lower systemic exposure with clinically relevant glucose lowering effects is an especially attractive proposition for the treatment of type 2 diabetes patients with renal impairment, as well as for patients unable to take full doses of metformin due to gastrointestinal side effects."
In the study, Metformin DR exhibited clinically significant dose-related reductions versus placebo in HbA1c and fasting plasma glucose. The glycemic effect of Metformin DR was somewhat less than that seen with a maximally effective dose of metformin immediate release (IR), but with significantly and disproportionally lower systemic exposure. The subgroup of subjects who completed the study and adhered to all protocol requirements showed a pattern of glycemic improvement comparable to that seen with the overall study population. Metformin DR was well tolerated and adverse events were consistent with the well-understood safety profile of metformin, with the most common ones being gastrointestinal effects such as diarrhea and nausea. Metformin DR exhibited a favorable gastrointestinal side effect profile that warrants further development.
The multicenter, randomized, Phase 2b study enrolled 571 subjects with type 2 diabetes and evaluated the glycemic effects of Metformin DR at doses of 600, 900, 1200 and 1500 milligrams, once daily. The study included a single-blind comparator arm of subjects receiving 2000 milligrams of metformin IR per day, administered as equally divided doses (1000 milligrams of metformin IR twice daily).
"The study results confirm that glucose-lowering benefits of Metformin DR result from actions in the gut," said Alain Baron, M.D., president and chief executive officer of Elcelyx. "The study also determined doses to be studied in Phase 3. With its robust size and duration, the Phase 2b study provides good support for the design of pivotal studies in type 2 diabetes patients with more advanced renal disease and those with gastrointestinal intolerance to metformin."
The company's research that supports the potential benefits of Metformin DR for diabetes patients with renal impairment will be presented next week at the American Society of Nephrology's Kidney Week 2016. Elcelyx Chief Scientific Officer Mark Fineman, Ph.D. and collaborators will present results of a clinical study showing that an optimal daily dose of Metformin DR may provide an alternative for subjects with moderate and severe kidney disease.
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 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.
Pam Lord, Canale Communications
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SOURCE Elcelyx Therapeutics