Microbia Announces Positive Phase 2 Results for Its Investigational Compound Linaclotide
CAMBRIDGE, Mass., May 21, 2007 /PRNewswire/ -- Microbia today announced the presentation of data from a Phase 2 study in which linaclotide accelerated colonic transit and improved bowel function in patients with constipation- predominant irritable bowel syndrome (IBS-C). These data also showed linaclotide was well tolerated with a low incidence of adverse events. Linaclotide is a first-in-class compound currently being developed for the treatment of IBS-C, chronic constipation (CC), and other gastrointestinal disorders. Linaclotide is an agonist of the guanylate cyclase type-C receptor and acts by a different mechanism than agents targeting the serotonergic system. The results of this study are being presented today by Mayo Clinic investigator Viola Andresen, M.D. at the Digestive Disease Week conference in Washington, DC.
Study Design and Results
Thirty-six women suffering from IBS-C were evaluated in a double-blind, placebo-controlled study, which consisted of a five-day baseline and a five- day treatment period. The endpoints were measurements of gastrointestinal transit and bowel function. Gastrointestinal transit is the process of moving food or other substances through the intestinal tract. Gastrointestinal transit time is generally delayed in patients with IBS-C and is associated with the symptoms of constipation, such as hard stools. Patients who received linaclotide had a significant acceleration of ascending colon emptying and colonic transit at 48 hours post dose as measured by scintigraphy. Patients receiving linaclotide also showed significant improvements in stool consistency (i.e., stools were less hard), stool frequency, straining, and time to first bowel movement. Measurements of the preceding parameters were statistically significant relative to placebo treatment, with p-values of < 0.05 for each. No significant effects on upper intestinal transit were detected.
"We are pleased that these results complement our previous study with linaclotide in patients suffering from chronic constipation," said Mark Currie, Ph.D., Microbia's senior vice president of research and development. "These data greatly expand our understanding of the potential beneficial actions of linaclotide in patients with lower bowel dysfunction and provide an impetus to advance this agent in later stage clinical development."
Linaclotide is a first-in-class compound currently being tested for the treatment of IBS-C, CC and other gastrointestinal disorders. Linaclotide is an agonist of guanylate cyclase type-C, a receptor found on the lining of the intestine. In preclinical testing linaclotide was shown to increase fluid secretion into the intestine, accelerate intestinal transit, and decrease visceral pain. Linaclotide was designed to exert its effect on the intestine with minimal systemic exposure. In Phase 1 testing linaclotide was well tolerated and was not detected in the systemic circulation of healthy subjects. Linaclotide is currently being studied in a pair of Phase 2 dose- ranging trials for IBS-C and CC.
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. Patients with IBS often have altered patterns of gastrointestinal motility which contribute to symptoms. Colonic transit that is too rapid results in diarrhea, while delayed colonic transit results in constipation. 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 no therapies approved to treat the nine million U.S. patients diagnosed with IBS-C.
About Chronic Constipation (CC)
Twenty-six million Americans suffer from CC. 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 the Digestive Disease Week (DDW)
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19-24, 2007, at the Washington Convention Center, Washington, DC. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
About Microbia, Inc.
Microbia (www.microbia.com) is an entrepreneurial pharmaceutical company dedicated to the science and art of great drugmaking. Three 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 and MD-3124 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.
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Posted: May 2007