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Microbia Announces Initiation of Phase I Clinical Trial for Novel, ORAL IBS Treatment

Posted on: Monday, 1 November 2004, 12:00 CST

CAMBRIDGE, Mass., Nov. 1 /PRNewswire/ -- Microbia, Inc. today announced the initiation of a Phase I clinical trial of MD-1100, a novel-mechanism, orally administered compound under investigation for the treatment of irritable bowel syndrome (IBS). MD-1100 is a potent superagonist of guanylate cyclase-C, a receptor found on the surface of intestinal cells. Preclinical studies show that MD-1100 acts on the key defining attributes of IBS, increasing gastrointestinal transit and secretion while decreasing gastrointestinal pain. In addition, the Microbia drug discovery team crafted MD-1100 to specifically target the intestine-the site of disease-without more general systemic exposure, which may result in safety advantages for patients. The primary objectives of the Phase I studies are to evaluate the safety, pharmacokinetic, and pharmacodynamic properties of MD-1100 in healthy volunteers.

"Microbia is extremely pleased that MD-1100 is moving forward into clinical studies. Based on the positive preclinical data achieved to date, we are hopeful that this product may address the significant unmet medical need of patients suffering from IBS," said Peter Hecht, Chief Executive Officer at Microbia. "MD-1100, as the first product candidate in Microbia's therapeutic pipeline to enter into clinical development, provides initial validation of our drug-making expertise. With initiation of these clinical studies, we are taking another step toward our goal of building a fully integrated pharmaceutical company."

About Irritable Bowel Syndrome

One out of six adults in developed countries suffers from irritable bowel syndrome (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 (c-IBS), diarrhea-predominant (d- IBS), and alternating (a-IBS)-30% to 40% of patients suffer from c-IBS. There are currently few available therapies to treat the symptoms of IBS.

About Microbia

Microbia (http://www.microbia.com/) creates and develops innovative human medicines. The Company is advancing four novel drug candidates-treatments for gastrointestinal disorders, dyslipidemia, pain, and fungal infections. Microbia's Precision Engineering(TM) business unit generates cash to fund the therapeutics effort by improving biomanufacturing efficiencies for leading pharmaceutical and chemical manufacturers. Microbia has raised $99 million of equity capital and is located in Cambridge, Mass.

Microbia, Inc.

CONTACT: Corporate Inquiries: Susan Brady of Microbia, Inc.,+1-617-621-8304; or Media Inquiries: Paul Kidwell of Kidwell Public Relations,+1-617|296-3854

Web site: http://www.microbia.com/


Source: PRNewswire

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