Barinthus Bio Begins Phase 1 Trial of VTP-1000 for Celiac Disease Treatment

Barinthus Biotherapeutics plc, a clinical-stage biopharmaceutical company, has announced the initiation of its first-in-human Phase 1 trial for VTP-1000, an investigational immunotherapy candidate designed to address celiac disease. The trial will assess the safety and tolerability of the treatment in adults with celiac disease, a condition affecting an estimated one in 100 people globally, for which no approved treatments currently exist.

The Phase 1 AVALON trial plans to enroll 42 participants and will be conducted in two stages. The first stage is a randomized, double-blind, placebo-controlled single ascending dose (SAD) phase. This will be followed by a multiple ascending dose phase, also randomized and double-blind, incorporating a controlled gluten challenge to evaluate the impact of VTP-1000 on patients' gluten exposure.

VTP-1000 utilizes Barinthus Bio’s proprietary SNAP-TI platform, which co-delivers multiple gluten-derived peptide antigens from wheat, barley, and rye proteins, along with the immunomodulator rapamycin, in nanoparticles. The goal is to promote immune tolerance to gluten, a protein that triggers an autoimmune response in people with celiac disease, causing inflammation and gastrointestinal symptoms.

Dr. Leon Hooftman, Chief Medical Officer of Barinthus Bio, mentioned that celiac disease can significantly impact daily life due to the common presence of gluten in many foods, making strict avoidance challenging. When individuals with celiac disease consume gluten, even in small amounts, it triggers an autoimmune response that leads to inflammation and rapid gastrointestinal symptoms. Over time, this can result in damage to the small intestine's lining, leading to malnutrition and vitamin deficiencies.

Dr. Nadège Pelletier, Chief Scientific Officer of Barinthus Bio, expressed excitement about bringing VTP-1000 and the SNAP-TI platform to the clinic. She emphasized the importance of restoring immune system tolerance to gluten to prevent or reduce inflammation in the small intestine following gluten exposure.

Celiac disease is an autoimmune disorder caused by a reaction to dietary gluten, which is found in wheat, barley, and rye. The condition leads to an autoimmune response dominated by T effector cells, causing inflammation and a variety of symptoms, such as vomiting, diarrhea, and long-term damage to the mucosal lining of the small intestine. Avoiding gluten entirely is currently the only recommendation for managing the disease, a task complicated by widespread gluten presence and cross-contamination.

Barinthus Bio specializes in developing innovative immunotherapeutic candidates aimed at guiding the immune system to combat chronic infectious diseases and autoimmunity. Their pipeline includes VTP-300, which uses the ChAdOx/MVA platform for a potential cure for chronic HBV infection, and VTP-850, a second-generation immunotherapy for recurrent prostate cancer.

The company is driven by a commitment to improving the lives of individuals with serious diseases and their families. With their proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic products for conditions like infectious diseases and autoimmunity. Their unique approach and scientific expertise position them to deliver transformative treatments for chronic diseases.