Barinthus Biotherapeutics plc has initiated a Phase 1 clinical trial of VTP-1000, a novel immunotherapeutic candidate for the treatment of celiac disease. The first-in-human trial aims to evaluate the safety and tolerability of VTP-1000 in adult patients with celiac disease, a condition affecting an estimated one in 100 people worldwide. The study is a randomized, placebo-controlled trial that includes a controlled gluten challenge.
AVALON Trial Design
The Phase 1 AVALON trial (NCT06310291) is designed to enroll 42 participants with celiac disease. The trial consists of two parts: a randomized, double-blind, placebo-controlled single ascending dose (SAD) phase, followed by a randomized, double-blind, placebo-controlled multiple ascending dose phase. The multiple ascending dose phase incorporates a controlled gluten challenge to assess the impact of VTP-1000 administration on patients' exposure to gluten.
VTP-1000 Mechanism of Action
VTP-1000 is an investigational, injectable antigen-specific tolerance immunotherapy. It utilizes Barinthus Bio’s proprietary SNAP-TI platform to co-deliver multiple gluten-derived peptide antigens (from wheat, barley, and rye proteins) and the immunomodulator rapamycin in nanoparticles. This approach aims to promote immune tolerance to gluten in individuals with celiac disease.
Unmet Need in Celiac Disease
Celiac disease is an autoimmune disorder triggered by dietary gluten. When individuals with celiac disease consume gluten, their body mounts an autoimmune response, leading to inflammation and damage to the lining of the small intestine. This can result in rapid gastrointestinal symptoms and long-term complications such as malnutrition and vitamin deficiencies. Currently, there are no approved treatments for celiac disease, and the primary management strategy involves strict avoidance of gluten, which can be challenging due to its prevalence in the Western diet.
Expert Commentary
Dr. Leon Hooftman, Chief Medical Officer of Barinthus Bio, noted the burden of accidental gluten ingestion in everyday life for those with celiac disease. Dr. Nadège Pelletier, Chief Scientific Officer of Barinthus Bio, expressed excitement about the first clinical application of VTP-1000 and the SNAP-TI platform, emphasizing the goal of restoring immune system tolerance to gluten by balancing regulatory and pathogenic effector T cells to prevent or reduce inflammation in the small intestine following gluten exposure.
