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Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes
Date:5/20/2013

ewMet has long-term glucose lowering benefits with a tolerability and safety profile that is superior to currently marketed metformin, the #1 diabetes product in the world. This would allow many more patients with Type 2 diabetes to enjoy the full benefit of metformin's active ingredient."

In Phase 2a studies in patients with Type 2 diabetes, NewMet reduced fasting plasma glucose to a similar extent as generic metformin but had improved tolerability.  Pharmacokinetic/pharmacodynamic studies have shown that glucose lowering and augmented release of the gut hormones peptide YY (PYY) and glucagon-like peptide-1 (GLP-1) were similar to generic metformin despite NewMet's dramatically lower plasma exposure.

By targeting the lower gut and reducing systemic absorption, NewMet may be appropriate for the large population of renally impaired patients with Type 2 diabetes that are contraindicated for metformin use due to the risk of lactic acidosis, a life-threatening result of metformin build-up in the blood. There are few safe and sufficiently effective oral agents to treat Type 2 diabetes patients with renal impairment. Elcelyx plans to initiate a pharmacokinetics/pharmacodynamics study of NewMet in Type 2 diabetes patients with mild, moderate and severe renal impairment. The study is expected to begin this summer.

NewMet is also an ideal candidate for fixed-dosed combinations with other oral antidiabetic agents, such as DPP4is and SGLT2is, because it can deliver a maximally effective dose of metformin in a single once-daily tablet and does not require titration.

About Elcelyx Therapeutics
Elcelyx Therapeutics develops pharmaceutical and consumer healthcare products based on its proprietary Gut Sensory Modulation (GSM) platform. Pharmaceutical product candidate NewMet™ is being developed for use by Type 2 diabetes patients who have difficulty tolerating generic metformin or are contraindicated for its
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SOURCE Elcelyx Therapeutics
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