Hamburg-based Topas Therapeutics announced plans to present clinical Phase 2a data for its lead candidate TPM502 in celiac disease at the upcoming Digestive Disease Week (DDW) 2025, scheduled for May 3-6 in San Diego, California.
The company's innovative treatment approach utilizes tolerizing nanoparticles carrying crucial gluten epitopes for HLA-DQ2.5, a genetic variant present in the majority of celiac disease patients. According to topline results announced in October 2024, the Phase 2a trial demonstrated persistent, antigen-specific tolerogenic effects in patients with celiac disease.
The abstract has received significant recognition, being selected for presentation in two separate sessions at DDW, including the American Gastroenterological Association (AGA) Clinical Science Plenary and the AGA Presidential Plenary.
Novel Mechanism of Action
TPM502 represents a potentially groundbreaking approach to treating celiac disease, an autoimmune condition affecting approximately 1% of the global population. The therapy employs Topas' proprietary platform of antigen-coupled nanoparticles that target liver sinusoidal endothelial cells to drive T cells toward tolerance.
This mechanism aims to address the root cause of celiac disease rather than merely managing symptoms. By inducing immune tolerance to specific gluten epitopes, TPM502 could potentially allow patients to consume gluten-containing foods without triggering the damaging immune response characteristic of the disease.
Presentation Details
Dr. Knut Lundin, Principal Investigator of the Phase 2a study and Professor at the University of Oslo, will present the findings in two sessions:
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AGA Clinical Science Plenary
- Monday, May 5th, 08:00 – 9:30 am PDT
- Abstract Title: "Safety, Tolerability and Pharmacodynamic Effects of TPM502, a Mixture of Tolerizing Nanoparticles for Treatment of Celiac Disease (CeD)"
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AGA Presidential Plenary: AGA at its Best and the Best of AGA
- Monday, May 5th, 10:00 – 11:30 am PDT
- Abstract Title: "Safety, Tolerability and Pharmacodynamic Effects of TPM502, a Mixture of Tolerizing Nanoparticles for Treatment of Celiac Disease (CeD)"
The selection for presentation at these prestigious sessions underscores the potential significance of the findings for the field of gastroenterology.
Implications for Celiac Disease Treatment
Celiac disease currently has no approved pharmacological treatments, with strict gluten avoidance being the only management option. This dietary restriction poses significant challenges for patients, affecting quality of life and carrying risks of inadvertent gluten exposure.
If successful in later-stage trials, TPM502 could represent the first disease-modifying therapy for celiac disease, potentially reducing or eliminating the need for strict dietary restrictions. The positive Phase 2a results suggest that the treatment may provide durable benefits by reprogramming the immune system's response to gluten.
Broader Platform Potential
According to Topas Therapeutics, the positive results from the celiac disease trial validate their technological platform's potential beyond this single indication. The company believes their approach could address a broad range of autoimmune and immune-mediated conditions that currently lack effective treatments.
"The topline readout from our Phase 2a clinical trial in celiac disease validates the potential of this new drug modality and its potential to address a broad range of immune-mediated indications, positioning us to deliver significant therapeutic benefits to patients," stated the company in their announcement.
About Digestive Disease Week
DDW represents the largest international gathering of physicians, researchers, and academics in gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. The 2025 meeting will showcase more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine, and technology.
The conference is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
For celiac disease patients and the medical community, the upcoming presentation of TPM502 data represents a potentially significant step forward in developing effective treatments for this challenging autoimmune condition.
