Case Studies

case studies
Find out who is doing what with the Pharmaprojects Search Tool and how they are doing it..

Pharma R&D Pipeline Intelligence

Our pharmaceutical research commentary & drug development news are derived from Pharmaprojects' R&D pipeline intelligence data. Pharmaprojects' research & development pipeline intelligence is your answer to an increasingly competitive pharmaceutical market...
..more about us

Conference Reports

Digestive Disease Week
Washington, DC, USA, 19th - 24th May 2007

In the bustling hubbub of downtown Washington, DC, attendees gathered at the Convention Center for the 2007 Digestive Disease Week. Sponsored by the combined strength of the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), the much anticipated DDW meeting proved once again to be the largest assembly of intellectuals in the field of gastroenterology and hepatology.

digestive disease week at the DC conference center.

It seemed that a great deal of the conference this year was focused on diagnosis and surgical treatment of gastrointestinal disorders. Various clinical update sessions, research forums and symposia where sub-divided into specific themes, including irritable bowel syndrome (IBS), nonalcoholic fatty liver disease, various cancers, and the possible links between obesity and gastrointestinal disorders. Another area of development that was a common theme was the utilisation of probiotics and their efficacy in various conditions, particularly irritable bowel disease. In fact, many of the presenters in the large underground exhibit hall were offering various pro and prebiotic drinks, snacks and advice.

In a notable press conference on Sunday entitled 'New Approaches to Managing Hepatitis', results of a Phase II trial of celgosovir in combination with peginterferon-α2b and ribavirin were presented. The trial, in chronic hepatitis- C genotype-1 patients who were either partial or non-responders, showed an early viral response in nonresponders of 42%, compared with only 10% for patients on peginterferon-α2b and ribavirin alone. The addition of celgosovir to the regime also decreased the mean viral load.

In the same press conference, researchers also reported on the retrospective analysis of trials in hepatitis- C patients who were also administered a statin at some point during their treatment. Currently, the US FDA and other health authorities worldwide suggest the use of statins in patients with 'active liver disease' as potentially unsafe. This ruling was initially instigated due to the possible link between alanine transaminase (ALT) levels and liver damage. It has since come to light that ALT levels are not an accurate measure of severity of liver disease, and as such levels of total bilirubin were measured as a better indicator. In a 14-day study, fluvastatin had no effect on bilirubin in patients with normal ALT levels and actually improved levels in 92% of patients with abnormal ALT levels. A further study, where patients had taken peginterferon and ribavirin with either simvastatin, lovastatin, atorvastatin or fluvastatin, showed an improvement in sustained viral response (SVR): without the use of a statin, the SVR was 37% and with the use of statins SVR was 63%. During this analysis, the only statin which seemed of no use in this circumstance was pravastatin.

Another key area for development was highlighted in a section entitled 'Progress in 2007: Important New Therapies for IBD and IBS', during which researchers presented details on a variety of treatments for an assortment of conditions. GlaxoSmithKline presented efficacy data for rosiglitazone, a drug launched for Type II diabetes, in the treatment of mild-to-moderately active ulcerative colitis, which is refractory or intolerant to 5- aminosalicyclic acid. After 12 weeks of treatment, 44% had achieved a clinical response with a higher rate of clinical remission and improvements in quality of life also evident. In another presentation, Microbia reported the use of linaclotide acetate in the treatment of constipation- predominant IBS. Currently in Phase II trials, this product effectively accelerated colonic transit and bowel habits with no evident safety issues. Sucampo Pharmaceuticals also released interesting data on lubiprostone, which is currently only launched in the US for constipation. In 2 Phase III trials in IBS, it demonstrated superiority versus placebo and side-effects were comparable, with discontinuation rates higher in the placebo group.

This year's Digestive Disease Week also showcased an abundance of other kinds of activities. With over 300 companies and 1000 booths filling the exhibition hall, offering anything from massage sessions to computer simulation games of drug action, and the profusion of captivating posters filling another large hall, the conference was a busy hive of activity for the week. Add to this various presentations, sponsored dinners and focused sessions in some of the most prestigious hotels in Washington, DC, DDW once again lived up to its reputation as the cornerstone of gastrointestinal conferences.

The next Digestive Disease Week will be held in San Diego, CA, USA 17th - 22nd May 2008.

Rebecca Bridge
Pharmaprojects Analyst