Microbia presents drug to treat constipation
drug for the treatment of constipation-predominant irritable bowel
syndrome (IBS-C) and chronic constipation (CC), demonstrated
promising pharmacodynamic effects.
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.
Its drug candidate MD-1100 (linaclotide acetate), was the focus of a Phase 1b clinical study that showed gastrointestinal (GI) pharmacodynamic effects, which may have the potential to alleviate the symptoms of these conditions, and no detectable systemic exposure.
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.
The data was presented this week at the Digestive Disease Week conference in Los Angeles, the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
The meeting also gave the researchers the opportunity to present 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.
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 per cent of adult visits to primary care physicians and is the most common disorder diagnosed by gastroenterologists.
Health care costs associated with IBS exceed $25bn (€19.5bn) annually. Of the three IBS subgroups - constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), and alternating (IBS-A) - 30 per cent to 40 per cent of patients suffer from IBS-C. There are currently few available therapies to treat the symptoms of IBS.
