CAMBRIDGE, Mass., May 23 /PRNewswire/ -- Microbia, Inc. today announced presentation of data from clinical and nonclinical studies with MD-1100 (linaclotide acetate), the Company’s first-in-class investigational drug for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic constipation (CC). The Phase 1b clinical study showed gastrointestinal (GI) pharmacodynamic effects, which may have the potential to alleviate the symptoms of these conditions, and no detectable systemic exposure. These data, presented this week at the Digestive Disease Week conference in Los Angeles, also indicate the drug is safe and well tolerated in healthy human volunteers.
The Phase 1b study showed linaclotide demonstrated GI pharmacodynamic effects throughout the course of the seven-day study as measured by a variety of markers related to intestinal transit, including stool consistency, stool weight, and time to first bowel movement. “We are encouraged by these results and the potential role for linaclotide as a new treatment option for patients suffering from IBS-C and other functional GI diseases,” said Peter Hecht, CEO of Microbia.
Also presented at this meeting, were data linking linaclotide’s target, guanylate cyclase-C (GC-C), to linaclotide’s ability to alleviate visceral pain in nonclinical models. Data presented by Dr. Lionel Bueno, of the INRA in Toulouse, France, show genetic deletion of GC-C eliminates linaclotide’s ability to reduce hyperalgesia. “Dr. Bueno’s data and the positive effects we observed on GI pharmacodynamics, in addition to the Phase 1 safety and tolerability profile of linaclotide, were all key to our decision to initiate Phase 2 studies in CC and IBS-C,” said Mark Currie, Microbia’s vice president of R&D.
About Chronic Constipation
As many as 42 million Americans suffer from constipation. Patients who suffer from CC often experience hard and/or 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 can greatly diminish a patient’s quality of life as it impacts their ability to work and participate in normal daily activities.
About Irritable Bowel Syndrome
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. Of the three IBS subgroups -- constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), and alternating (IBS-A) -- 30% to 40% of patients suffer from IBS-C. There are currently few available therapies to treat the symptoms of IBS.
About 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, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 20-25, 2006, at the Los Angeles Convention Center. 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 http://www.ddw.org.
About Microbia
Microbia (http://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 acetate for the treatment of constipation-predominant irritable bowel syndrome and other gastrointestinal disorders, and MD-0727 for the treatment of hypercholesterolemia. Microbia’s Precision Engineering(R) business unit collaborates with leading pharmaceutical and fine chemical manufacturers to improve efficiencies of existing fermentation processes or to create new bioprocesses. Microbia has raised $174 million in private equity financing and is located in Cambridge, Massachusetts.
Corporate Inquiries: Media Inquiries: Susan Brady Danielle Whitney Microbia, Inc. Biosector2 617|621-8304 212|845-5611 sbrady@microbia.comdwhitney@biosector2.com
Microbia, Inc.
CONTACT: Susan Brady of Microbia, Inc., +1-617-621-8304,sbrady@microbia.com; or Danielle Whitney of Biosector2 for Microbia, Inc.,+1-212-845-5611, dwhitney@biosector2.com
