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Ulcerative colitis: shedding light on emerging agents and strategies in preclinical and early clinical development
Berta Caballol1, Victoria Gudiño1, Julian Panes1
1Inflammatory Bowel Disease Unit, Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Centro de Investigaciones Biomédicas en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain.
Introduction:
Ulcerative colitis (UC) is an inflammatory disease of the large intestine. Progress in preclinical therapeutic target discovery and clinical trial design has resulted in the approval of new therapies. Nonetheless, remission rates remain below 30% thus underlining the need for novel, more effective therapies.
Areas Covered:
This paper reviews current experimental techniques available for drug testing in intestinal inflammation and examines new therapies in clinical development for the treatment of UC. The authors searched the literature for 'ulcerative colitis' AND 'preclinical' OR 'drug target/drug name' (i.e. infliximab, vedolizumab, IL-12, IL-23, JAK, etc.). Studies that included preclinical in vivo or in vitro experiments are discussed. The clinicaltrial.gov site was searched for 'ulcerative colitis' AND 'Recruiting' OR 'Active, not recruiting' AND 'Interventional (Clinical Trial)' AND 'early phase 1' OR 'phase 1' OR 'phase 2' OR 'phase 3.'
Expert Opinion:
Using in vivo, ex vivo, and/or in vitro models could increase the success rates of drugs moving to clinical trials, and hence increase the efficiency of this costly process. Selective JAK1 inhibitors, S1P modulators, and anti-p19 antibodies are the most promising options to improve treatment effectiveness. The development of drugs with gut-restricted exposure may provide increased efficacy and an improved safety.
Insights
New ulcerative colitis (UC) therapies show promise, but low remission rates highlight the need for better treatments. Preclinical models and gut-restricted drugs may improve therapeutic success and patient outcomes.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Ulcerative colitis (UC) is a chronic inflammatory bowel disease with suboptimal remission rates despite recent therapeutic advancements.
- There is a critical need for novel and more effective treatments to improve patient outcomes in UC.
Purpose of the Study:
- To review experimental drug testing techniques for intestinal inflammation.
- To examine novel therapies currently in clinical development for ulcerative colitis.
Main Methods:
- Literature search for 'ulcerative colitis' combined with preclinical research terms and specific drug targets (e.g., JAK inhibitors, vedolizumab).
- Inclusion of studies utilizing in vivo and in vitro preclinical models.
- Clinical trial data retrieval from ClinicalTrials.gov for active, recruiting UC interventional trials across early phases (1-3).
Main Results:
- Preclinical models (in vivo, ex vivo, in vitro) can enhance the success rate of drugs entering clinical trials.
- Selective JAK1 inhibitors, S1P modulators, and anti-p19 antibodies represent promising therapeutic avenues for UC.
- Gut-restricted drug development offers potential for improved efficacy and safety profiles.
Conclusions:
- Optimizing preclinical models is crucial for increasing drug development efficiency and success in UC.
- Emerging targeted therapies show significant potential to enhance treatment effectiveness for ulcerative colitis patients.
- Developing drugs with localized gut action may offer a superior risk-benefit balance.
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