The study is expected to be completed during the third quarter of 2008, with data available shortly thereafter. The results from this study will supplement the existing clinical database of more than 4,000 patients to form the basis of the company’s anticipated new drug application submissions to the FDA in early 2009 for Glinsuna (mitiglinide) and a fixed combination product, Metgluna, combining metformin and Glinsuna.
Elixir’s clinical study has enrolled more than 300 patients across 60 sites in the US and is designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients whose blood sugar is not adequately controlled by metformin alone. This study is expected to confirm results from a previously completed trial in Australia which demonstrated that the combination produced improved (lowered) A1c (HbA1c) levels versus metformin alone.
William Heiden, president and CEO of Elixir, said: “Completing enrollment in this final Phase III mitiglinide study moves us one step closer to providing important new therapy options to physicians and their type II diabetic patients. It also moves Elixir one step closer to achieving our goal of having commercial products fund the development of our ghrelin and SIR T products for the treatment of metabolic disease.”