"The participation of such high quality investors is a testament to the productivity of our talented team of drug hunters and the strength of our clinical programs and discovery pipeline," said Peter Hecht, CEO of Microbia. "Both of our innovative clinical candidates target the needs of millions of patients and continue to show potential in clinical studies. This infusion of equity capital will enable us to execute on our comprehensive development plans for these compounds and to advance our pipeline of therapeutic candidates."
Microbia is currently enrolling patients in a Phase 2 dose-ranging study investigating the safety and efficacy of linaclotide in patients with chronic constipation (CC). A second Phase 2 dose-ranging study in patients with constipation-predominant irritable bowel syndrome (IBS-C) will initiate in the first quarter of 2007. Together these studies will enroll more than 700 patients. Linaclotide is a first-in-class guanylate cyclase-C agonist that improved symptoms of CC and IBS-C in two Phase 2a clinical studies and demonstrated the ability to improve gastrointestinal transit and alleviate visceral pain in preclinical models.
Microbia also is enrolling patients with high cholesterol in a Phase 2 dose-ranging safety and efficacy study to investigate the potential of MD-0727 to lower LDL cholesterol. MD-0727 has been shown preclinically to be a potent cholesterol absorption inhibitor that acts in the lumen of the intestine and exhibits minimal systemic exposure-properties which have the potential to provide safety and efficacy advantages.
About Irritable Bowel Syndrome (IBS)
One out of six adults in developed countries suffers from IBS, a chronic condition marked by abdominal pain and disturbed bowel function. IBS accounts for 12% of adult visits to primary care physicians and is the most common disorder diagnosed by gastroenterologists. Health care costs associated with IBS exceed $25 billion annually. IBS patients fall into three subgroups- constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), and alternating (IBS-A)-and 30% to 40% of these patients suffer from IBS-C. There are currently few available therapies to treat the symptoms of IBS.
About Chronic Constipation (CC)
As many as 42 million Americans suffer from constipation. Patients with CC often experience hard and lumpy stools, straining during defecation, a sensation of incomplete evacuation, and may have fewer than three bowel movements in a week. The discomfort of CC significantly affects patients' quality of life by impairing their ability to work and participate in typical daily activities.
About Hypercholesterolemia and Cholesterol Absorption Inhibitors (CAIs)
The National Heart, Lung, and Blood Institute reports high blood cholesterol is one of the major risk factors for heart disease, which is the leading cause of death in the United States and Europe. According to the American Heart Association, nearly 107 million American adults have elevated blood cholesterol values and could benefit from treatment.
Drug therapies that lower cholesterol reduce mortality and result in significant improvements in patients' cardiovascular health. The cholesterol product sector produces more than $25 billion in sales and continues to show significant growth, fueled by multiple published clinical studies demonstrating the benefits of more aggressive cholesterol-lowering therapies. These studies led to the recent introduction of more aggressive cholesterol- management guidelines by the National Cholesterol Education Program (NCEP).
CAIs work in a manner distinct from traditional cholesterol medications known as statins. CAIs reduce the amount of cholesterol absorbed from the digestive tract, whereas statins inhibit the production of cholesterol in the body. Studies have shown combining CAIs with statins can result in greater cholesterol lowering than is achieved using either therapy alone.
About Microbia
Microbia (www.microbia.com) is an entrepreneurial pharmaceutical company dedicated to the science and art of great drugmaking. Two of the Company's drug candidates are in clinical studies-linaclotide for the treatment of constipation-predominant irritable bowel syndrome, chronic constipation, and other gastrointestinal disorders, and MD-0727 for the treatment of hypercholesterolemia. Microbia Precision Engineering, Inc., a majority-owned subsidiary of Microbia, Inc., is an industrial biotechnology company developing and commercializing novel bioprocesses for the production of specialty chemicals, both independently and with strategic partners. Microbia has raised $231 million in private equity financing and is located in Cambridge, Massachusetts.
Contact: Susan Brady Corporate Communications 617|621-8304 sbrady@microbia.com
Source: Microbia, Inc.
