Barinthus Biotherapeutics
Barinthus Biotherapeutics plc, a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease, has announced the initiation of its first-in-human Phase 1 trial of VTP-1000 in adults with coeliac disease.
The randomised, placebo-controlled clinical trial, which includes a controlled gluten challenge, will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000.
The Phase 1 AVALON trial (NCT06310291) aims to enrol 42 participants with coeliac disease and will be conducted in two parts: a randomised double-blind placebo controlled single ascending dose (SAD) part, followed by a randomised double-blind placebo-controlled multiple ascending dose part, incorporating a controlled gluten challenge to assess the impact of VTP-1000 administration on patients’ exposure to gluten.
VTP-1000 is an investigational, injectable antigen-specific tolerance immunotherapy that utilises 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 to promote immune tolerance to gluten.
“When a person with coeliac disease eats even small amounts of gluten, their body mounts an autoimmune response that causes inflammation resulting in rapid gastrointestinal symptoms and damage to the lining of the small intestine. This can be a burden in everyday life, as accidental ingestion is very common, and gluten avoidance can be difficult due to prevalence of the protein in the western diet,” said Dr. Leon Hooftman, Chief Medical Officer of Barinthus Bio.
“Coeliac disease remains an area that currently does not have any approved treatments. VTP-1000 aims to restore immune system tolerance to gluten and we are very excited to see VTP-1000 and the SNAP-TI platform in the clinic for the first time,” added Dr. Nadège Pelletier, Chief Scientific Officer of Barinthus Bio. “Restoring the correct balance of regulatory over pathogenic effector T cells aims to prevent or reduce inflammation in the small intestine following exposure to gluten."
Coeliac disease is caused by an autoimmune response to dietary gluten. It is relatively common, impacting an estimated one in 100 persons of all ages (approximately 80 million people globally) and increasing in incidence. When people with celiac disease eat even small amounts of gluten-containing foods, their body mounts an autoimmune response consisting of T effector cells that cause inflammation.
This can lead to rapid onset of symptoms (vomiting, diarrhoea, etc.), as well as damage to the mucosal lining of the small intestine that can cause long term consequences (e.g., malnutrition and vitamin deficiencies). Coeliac disease is an area of high unmet need with no currently approved treatments; instead, people with celiac disease are advised to strictly avoid consuming gluten, which can be difficult due to the presence of gluten in many foods and cross-contamination of food production surfaces.