More than 18,000 gastroenterologists and related health care providers gathered at the Digestive Disease Week conference in New Orleans to gain new information on gastrointestinal research, medicine and technology.
Among data reported at the meeting:
• Abbott Laboratories, of Abbott Park, Ill., said data demonstrate that patients with moderate to severely active Crohn's disease treated with Humira (adalimumab) achieved remission and clinical response in two different trials. In one, a pivotal Phase III study in active Crohn's disease, treatment with Humira induced a statistically significant increase in remission at four weeks, compared to placebo. In an open-label, investigator-initiated study of Crohn's patients who had lost response to or became intolerant to infliximab, 59 percent of them with moderate to severely active disease achieved clinical response at 12 weeks.
• ARYx Therapeutics Inc., of Santa Clara, Calif., reported preclinical pharmacology data on ATI-7505 in an abstract titled "ATI-7505 Is a Novel, Selective 5HT4 Receptor Agonist That Causes Gastrointestinal Prokinetic Activity in Dogs."
• Microbia Inc., of Cambridge, Mass., said preclinical data demonstrated that MD-1100 relieves gastrointestinal pain and promotes gastrointestinal transit in treating irritable bowel syndrome. Specifically, it increased gastrointestinal transit by 49 percent and increased gastrointestinal secretion by 87 percent in multiple in vivo models. The orally delivered compound is a superagonist of guanylate cyclase-C, a receptor found on the surface of intestinal cells. It was designed to target the intestine, the site of disease, without more general systemic exposure.
• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said data from a 220-patient trial showed that 85 percent of rifaximin-treated subjects remained free of diarrhea, compared with 49 percent of placebo-treated subjects. The trial was evaluating the drug's use as a prophylaxis for travelers' diarrhea. A separate study of 86 patients with colonic polyps who were treated with balsalazide or placebo for six months showed that though the change in size and number of adenomas did not significantly differ between groups, a trend was seen toward reduced total adenoma volume in those receiving balsalazide.
• Santarus Inc., of San Diego, reported results from its pivotal Phase III trial of Rapinex (omeprazole) immediate-release powder for oral suspension 40 mg for the prevention of upper gastrointestinal bleeding in critically ill patients. Findings showed that two hours after the first dose, the median gastric pH was 7.8 for Rapinex-treated patients and 6.4 for cimetidine-treated patients (p<0.001). Using acid-reducing agents, the therapeutic goal in critically ill patients is to raise gastric pH above 4. Failure to control gastric pH (pH<4 on two successive measurements) occurred during the 14-day trial in 58 percent of cimetidine-treated patients and in 18 percent of Rapinex-treated patients, leading to an increase of the cimetidine dose in 53 percent of patients and the Rapinex dose in 15 percent (p<0.009).
• Solvay Pharmaceuticals Inc., a unit of Solvay Pharmaceuticals BV, of Brussels, Belgium, said Phase III data showed that treatment with cilansetron resulted in significant relief of abdominal pain/discomfort and abnormal bowel habits in male and female patients with irritable bowel syndrome with diarrhea predominance. In a sub-analysis of male patients, data showed significant treatment benefits among patients receiving cilansetron, including improvement in overall IBS symptoms, abdominal pain/discomfort and abnormal bowel habits. Solvay, which has completed three Phase III studies of the 5-HT3 antagonist, submitted cilansetron for approval in the UK last month and plans to submit a new drug application to the FDA this quarter.