Barinthus Bio Initiates Phase 1 Clinical Trial of for the Treatment of Celiac Disease

Barinthus Biotherapeutics plc recently announced the initiation of its first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease. The randomized, 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 enroll 42 participants with celiac disease and will be conducted in two parts: a randomized double-blind placebo controlled single ascending dose (SAD) part, followed by a randomized 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 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 to promote immune tolerance to gluten.

“When a person with celiac 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.

“Celiac 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.

Celiac 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, diarrhea, etc), as well as damage to the mucosal lining of the small intestine that can cause long term consequences (eg, malnutrition and vitamin deficiencies). Celiac 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.

Barinthus Bio is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around our proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in infectious diseases and autoimmunity, including: VTP-300, that utilizing our ChAdOx/MVA platform designed as a potential component of a functional cure for chronic HBV infection and VTP-1000, utilizing our SNAP-Tolerance Immunotherapy (SNAP-TI) platform and is designed to treat people with celiac disease. Barinthus Bio is also conducting a Phase 1 clinical trial for VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer. Barinthus Bio’s differentiated technology platforms and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with chronic infectious diseases and autoimmunity. For more information, visit www.barinthusbio.com.