Elixir Completes Enrollment in Pivotal Phase III Clinical Trial for New Diabetes Drug
CAMBRIDGE, Mass.– Elixir Pharmaceuticals, Inc.,announced today that it has completed enrollment in its final pivotal phase III clinical study of mitiglinide for the treatment of patients with type 2 diabetes. 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 (NDA) submissions to the FDA in early 2009 for Glinsuna™ (mitiglinide) and a fixed combination product, Metgluna™, combining metformin and Glinsuna.
“We are pleased to meet this important milestone in the development of these exciting product candidates,” stated Dr. Paul Martha, Chief Medical Officer and SVP, Clinical Development and Regulatory Affairs. “We believe Metgluna could become an important new treatment option for the more than five million metformin patients who will eventually require additional glucose control, and Glinsuna would offer a new treatment option for physicians and patients who prefer the dosing flexibility offered by the single agent.”
Elixir’s clinical study has enrolled more than 300 patients across 60 sites in the U.S. 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. In previous clinical studies, Glinsuna has been shown to significantly lower patients’ levels of hemoglobin HbA1c by mimicking the natural response to glucose by producing a rapid and brief burst of insulin to coincide with the rise in glucose levels following meals.
William K. Heiden, Elixir’s President and Chief Executive Officer stated, “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 blockbuster-potential ghrelin and SIR T products for the treatment of metabolic disease.”
About Type 2 Diabetes
Type 2 diabetes is a chronic metabolic disorder characterized by high blood sugar caused by defective insulin secretion, resistance to insulin action, or a combination of both. It is a serious and debilitating disease, affecting more than 20 million Americans in the U.S. alone, 30% of whom are estimated to be undiagnosed. While there has been significant progress in the treatment of type 2 diabetes in the last decade, there is still an enormous unmet medical need worldwide.
Approximately half of people diagnosed with type 2 diabetes have not achieved adequate blood sugar level control, as measured by HbA1c. HbA1c is a measure of average blood sugar over time and takes into account the baseline level of sugar (fasting plasma glucose) and the rises that occur after a meal (post-meal glucose). The American Diabetes Association recommends that patients with type 2 diabetes achieve a target HbA1c level of < 7%. Type 2 diabetes increases the risk for many serious complications, particularly heart disease, blindness, nerve damage and kidney damage, all of which can be reduced by tightly controlling the level of blood sugar.
About Metgluna and Glinsuna
For patients with type 2 diabetes not well controlled on metformin alone, Metgluna™ will provide additional HbA1c reduction through comprehensive glycemic control via two complementary mechanisms of action. Metgluna is a fixed combination tablet of metformin, which helps control fasting plasma glucose by improving insulin sensitivity, and mitiglinide, a product that mimics the body’s natural response to glucose by producing a rapid and brief burst of insulin when glucose levels begin to rise following meals to provide for better control of post-meal glucose surges.
The companion product Glinsuna™ has been studied extensively in human clinical studies in the U.S., Europe, Australia, and Asia. Clinical trial results, including more than 1,500 patients treated in phase III trials, have demonstrated an excellent safety and efficacy profile for mitiglinide as monotherapy or in combination with metformin. An on-going phase III clinical study enrolled more than 300 patients across 60 sites in the U.S. and was designed to further evaluate the efficacy and safety of Glinsuna in combination with metformin in patients whose blood sugar is not adequately controlled by metformin alone in a representative U.S. population, a concept that has already been successfully demonstrated in a completed Australian phase III study.
Elixir in-licensed North and South American rights to mitiglinide from Kissei Pharmaceuticals in Japan, where the product is approved and has been used to treat several hundred thousand patients. Under the terms of the licensing agreement, Elixir has the right to develop and commercialize mitiglinide and any future product combinations, in the U.S., Canada and Latin America.
Contacts
Elixir Pharmaceuticals:
William Heiden
617-995-7000
or Burns McClellan for Elixir Pharmaceuticals
Media:
Justin Jackson
212-213-0006
jjackson@burnsmc.com
Investors:
Juliane Snowden
212-213-0006
jsnowden@burnsmc.com
or
Nicki Kahner
212-213-0006
nkahner@burnsmc.com
