R&D Trends: Inflammatory Bowel Disease - Unmet Needs Fuel Diverse Pipeline

Sep 20, 2011, 06:18 ET from Reportlinker

NEW YORK, Sept. 20, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

R&D Trends: Inflammatory Bowel Disease – Unmet needs fuel diverse pipeline


The current pipeline is highly dynamic, with new entries compensating for heavy early-stage attrition. Several high profile candidates have failed in late-stage trials, but first-in-class agents targeting compelling new mechanisms are generating excitement in Phase II/III. Key opinion leaders provide extra insight, and predict how trials and treatments will evolve in this growing disease area.Multi-parameter assessment of the inflammatory bowel disease (IBD) pipeline from preclinical to preregistration.Analysis of clinical trial design, highlighting the impact of regulatory guidelines and the need to standardize and quantify new endpoints.The key learnings from candidates recently discontinued from late-stage IBD clinical trials.Identifies the most promising innovative new candidates within the pipeline.In-depth interviews with four key opinion leaders reveals significant unmet needs and strong views on the direction of future research.Efficacious mechanisms for intervening in IBD progression prove elusive, but industry commitment remains high. Despite the discontinuation of three high-profile compounds during the past year, the IBD pipeline continues to grow as new mechanisms are trialed in the search for much-needed efficacy improvements.There is good consensus between key opinion leaders on the unmet needs of patients with both forms of IBD; Crohn's disease and ulcerative colitis. The tumor necrosis factor alpha (TNF) inhibitor Remicade (infliximab) remains the gold standard for treating both forms, but maintained remission rates show much room for improvement.Clinical trials have changed significantly to allow a more accurate assessment of a candidate's ability to either induce remission, prevent relapse, or both. A greater number of concurrent trials has necessitated studies in extra countries, forcing the industry to learn some costly lessons on the need for more rigorous inclusion criteria.What are the major unmet needs among IBD patients, and how may candidates within the current clinical pipeline be expected to address these?Are the clinical trial protocols and endpoints fully optimized to enable new biological mechanisms to be thoroughly evaluated?Which are the most anticipated candidates in the pipeline, and how may the portfolio of projects change over the next decade?Which areas of new research are being championed by leading gastroenterologists, and why?





•Strategic scoping and focus

•Datamonitor key findings

•Related reports


•Pipeline dominated by early-stage candidates

•The IBD pipeline is focused equally on Crohn's disease and ulcerative colitis

•Analysis by drug class reveals mode-of-action diversity

- TNF inhibitors are still attractive, despite the maturity of the target

- Corticosteroids exemplify drug delivery innovation

- Interest in IL-targeting agents has doubled during the past year

- The IBD pipeline contains a huge variety of mechanisms

- Two promising targets are under-represented within the pipeline

•Analysis by molecule type demonstrates breadth of options

- Monoclonal antibodies maintain pipeline prominence

- Interest in stem cell treatment grows

•Pfizer focuses more effort on IBD

•Late-stage development compounds recently discontinued

- Orencia

- Secukinumab

- Briakinumab


- Propionyl-L-carnitine


•Lack of consensus on choice of gold standards

•Remicade is the comparator therapy in Crohn's disease and ulcerative colitis

•Target product profile versus current level of attainment with Remicade reveals significant unmet needs

- Efficacy

- Safety

- Formulation

- Cost


•Recent trends among inflammatory bowel disease clinical trials

- Speed of remission onset

- Greater emphasis on mucosal healing

- Successful trials require thorough characterization of patients at enrollment

- The location and duration of clinical trials need careful planning

•Design of typical clinical trials

•Future developments in clinical trial design

- Improving activity indices

- More active comparator trials

- Measuring drug and/or cytokine levels in the blood


•Ranking of key innovative therapeutic approaches in inflammatory bowel disease

- Alpha-4 beta-7 integrin and MAdCAM-1 inhibitors

- JAK3 inhibitor

- IL-12/IL-23 and IL-23 inhibitors

- IL-6 inhibitors


•Key findings


•Journal papers


•Datamonitor reports


•Contributing experts

•Report methodology


•Table: Products in development for inflammatory bowel disease, July 2011

•Table: TNF inhibitors in the inflammatory bowel disease pipeline, July 2011

•Table: Corticosteroids in the inflammatory bowel disease pipeline, July 2011

•Table: IL-targeting agents in the inflammatory bowel disease pipeline, July 2011

•Table: Monoclonal antibodies in the inflammatory bowel disease pipeline, July 2011

•Table: Stem cell treatments in the inflammatory bowel disease pipeline, July 2011

•Table: Number of IBD pipeline candidates per company, July 2011

•Table: Products discontinued from inflammatory bowel disease pipeline, April 2010 to July 2011

•Table: Remicade drug profile, 2011

•Table: Ability of comparator therapy Remicade to meet unmet needs in inflammatory bowel disease, 2011

•Table: Most promising innovative early-stage approaches in inflammatory bowel disease, July 2011


•Figure: Inflammatory bowel disease pipeline, by highest development phase, July 2011

•Figure: Inflammatory bowel disease pipeline, by form of disease, July 2011

•Figure: Overview of therapeutic targets in Crohn's disease

•Figure: Inflammatory bowel disease pipeline, by class and development phase, July 2011

•Figure: Inflammatory bowel disease pipeline, by molecule type, July 2011

•Figure: Stelara Phase III clinical trial design for Crohn's disease

Companies Mentioned

Admiral Group plc, Chattem, Inc., GlaxoSmithKline Plc, Hutchison 3G UK Limited, Johnson & Johnson, K+S AG, Legg Mason, Inc., Novartis AG, Schindler Holding Ltd.

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Nicolas Bombourg
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