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Clinical Development

Highlights from Digestive Disease Week 2025

  • June 10, 2025

In May 2025, Medpace gastroenterology and operational experts attended Digestive Disease Week® (DDW) – one of the premier international events focused on gastroenterology, hepatology, and endoscopy. Learn more from Dr. Kelly Allred Metz, Medical Director, Dr. Robert McGee, Medical Director Laboratories and Frénel Joseph, Senior Director, Global Therapeutic Group Lead Gastrointestinal Trials, as they recap highlights from the conference.

A Leading Forum for GI Innovation

Digestive Disease Week® is one of the largest congresses in the US in the fields of gastroenterology, hepatology and endoscopy. Sponsored by several different physicians’ associations and societies including AGA (American Gastroenterological Association) and ASGE (American Society for Gastrointestinal Endoscopy), DDW brings together a global community of doctors, researchers, academics and industries.

The 2025 event was held in San Diego, California, with both in-person and virtual participation. Organizers reported over 13,000 attendees, 6,000 abstracts, and more than 1,000 lectures presented over the four days, covering the latest achievements in digestive disease research, medicine, and technology. It was a great opportunity for people with various backgrounds and interests to learn about current industry topics while experiencing networking opportunities.

Throughout the event, the Medpace team connected with fellow researchers, site leaders, patient advocacy groups, clients and innovators in GI health. The week fostered collaboration and offered valuable insights into both ongoing challenges and emerging solutions in the field.

Key Conference Takeaways  

DDW 2025 spanned a large variety of topics and sessions; from basic science to translational and clinical research in hepato-gastroenterology, with several interim trial results and insights from studies that are still ongoing.

There was notable excitement throughout the clinical sessions around the management of obesity and cutting-edge talks on inflammatory bowel disease, Crohn’s disease, ulcerative colitis and eosinophilic esophagitis.

A standout moment of the congress was a dedicated lecture session to Barry Marshall (Nobel Laureate 2005) and Adrienne Marshall Lecture (Latest Advances and Challenges in Helicobacter pylori Screening and Eradication).

The closing session spotlighted the importance of microbiome therapeutics, the field’s rapid growth over the past decade, and the way forward. But at the same time, the regulatory pathway is quite lagged with the first FDA approval starting only in 2011/2012. The spreading interest around the small intestinal microbiome was evident in several abstracted featured developments, strategies, mechanics of action, targets and current challenges in microbiome therapeutics and studies.

Our Recap Samples

During the session Clinical Trials in IBD: Biologics and Emerging Therapies, several late-breaking clinical trials were featured that highlighted advancements in gastroenterology and related fields. The following is a brief sampling of some of the notable studies:

Inflammatory Bowel Diseases (IBD)

Duvakitug Induction Treatment Improves Clinical and Endoscopic Outcomes in Moderately to Severely Active Ulcerative Colitis: An Endoscopic Subgroup Analysis of Data from the Relieve-UCCD Phase 2b Study

Summary:

  • Duvakitug induction therapy demonstrated greater clinical and endoscopic response rates versus placebo in ulcerative colitis (UC) patients irrespective of baseline disease severity as measured by endoscopic activity
  • Duvakitug was well tolerated with a similar safety profile observed in either subgroup
  • These findings support further development of duvakitug as a potential treatment option for patients with UC and moderate or severe endoscopic disease

Fibro Stenosing Crohn’s Disease (FSCD)

A Phase 2a, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of AGMB-129 In Patients with Fibrostenotic Crohn’s Disease: Interim Results from the Stenova Trial

Summary:

  • Fibro stenosing Crohn’s disease remains a significant unmet medical need
  • AGMB-129 is a locally acting ALK5 inhibitor with minimum systemic exposure
  • AGMB-129 is safe and well tolerated in patients with FSCD (primary endpoint)

Irritable Bowel Syndrome with Constipation (IBS-C)

A Randomised, Double-Blind, Placebo Controlled, Phase II Trial Assessing the Safety and Efficacy of EBX-102-02, An Oral Full-Spectrum Intestinal Microbiota Product, in Patients with Irritable Bowel Syndrome with Constipation; The TrIuMPH Trial

Summary:

  • EBX-102-02 was well tolerated and adverse events were mainly mild and gastrointestinal in nature
  • Promising efficacy signals across secondary endpoints in IBS-C cohort interim analysis
  • Drug to be evaluated in a Ph2b study with IBS-C patients

Mast Cell Depletion Therapy in Eosinophilic Esophagitis (EoE)

Summary:

  • Histology data from Phase 2 randomized, double-blind, placebo-controlled clinical trial of barzolvolimab (NCT05774184) where 300 mg of barzolvolimab or matching placebo is administered subcutaneously every 4 or 8 weeks in at least 75 patients with known EoE
  • Intraepithelial mast cells are elevated in active eosinophilic esophagitis and correlate with eosinophils: baseline data from a randomized controlled trial of barzolvolimab

Taking Full Advantage of Artificial Intelligence (AI)

One of the most striking presentations during DDW 2025 started with the following question: Can an artificial intelligence chatbot assistant, provide responses to patient questions that are of comparable quality and empathy to those written by physicians?

The speaker, Praveen Suthrum, presented some outputs from a study Comparing Physician and Artificial Intelligence Chatbot Responses to Patient Questions Posted to a Public Social Media Forum1. In this study, a certified board of oncologists evaluated ChatGPT’s responses against the physicians-generated responses based on quality, empathy, and readability. Remarkably, evaluators preferred chatbot responses to physician responses nearly 80% of the time. AI represents one of the most transformative forces which is now present in everyone’s talks, but not clearly defined in medicine yet.

Lastly, Medpace underscores the growing role of histopathology in advancing personalized medicine and improving therapeutic outcomes in gastrointestinal diseases.

Supporting Clinical Research in Gastroenterology & Hepatology

Medpace is the leading GI and hepatology CRO with experience across Phase I-IV gastroenterology and hepatology trials, supporting a broad spectrum of indications. As a full-service CRO with a proven track record, we deliver the scientific insight, operational excellence, and flexibility needed to navigate the complexities of each study and accelerate progress for patients. We welcome the opportunity to discuss your upcoming clinical development in gastroenterology & hepatology.

References
  1. John W. Ayers, PhD, MA1,2; Adam Poliak, PhD3; Mark Dredze, PhD4; et al