Phase 1 First-in-Human Study Assessing VTP-1000 in Adult Patients with Celiac Disease

A new Phase 1 study is recruiting participants in the US at a limited number of clinical sites.

Kate Avery, Senior Director of Coalition & Patient Engagement

AVALON is a Phase 1 clinical trial that aims to assess the safety and tolerability of VTP-1000, a potential treatment for celiac disease. AVALON is being sponsored by Barinthus Biotherapeutics North America and is being conducted in 16 locations across the United States. 

VTP-1000 is a targeted immunotherapy designed to prevent or reduce symptoms of celiac disease from accidental gluten exposure by promoting tolerance to gluten. Immune tolerance is one of the different approaches to potential treatments currently in the global drug development pipeline for celiac disease. 

Clinical trials are voluntary research studies conducted in people that are designed to answer specific questions about the safety and efficacy of treatments. Clinical trials help regulators, like the FDA, understand how new treatments can be used and help understand if they are safe and efficacious to use in people. AVALON is a Phase 1 clinical trial which means that a new treatment is being tested in a small group of people for the first time. 

The AVALON Study is looking for people aged 18 years and older with biopsy-diagnosed celiac disease who have been following the gluten-free diet for at least the last 12 months and do not have ongoing celiac disease symptoms. VTP-1000 will be administered as an intermuscular injection in the upper arm, like a shot. The study is being conducted in two parts: Part A and Part B. Part A – Single Ascending Dose (SAD) assessed a single dose of VTP-1000 at three different dose levels across three groups (one dose level per group) that increased sequentially. Nearing completion, Part A is expected to be fully enrolled in the coming weeks. Therefore, the remaining patients who screen and are deemed eligible for participation will take part in Part B of the study. Part B – Multiple Ascending Dose (MAD) assesses three consecutive doses of VTP-1000 at two-week intervals at the same dose levels administered in Part A of the study. 

Participants enrolled in Part B will be followed for 2 months with 9 visits to the study site. Prior to enrollment, there will be a screening period of up to 35 days (1 visit) to confirm eligibility. Participants will receive three doses of the study drug or placebo over 30 days (1 dose every 2 weeks) and complete a one-day single-dose gluten challenge two weeks after the last dose of VTP-1000 is given. Follow-up visits in the clinic and phone calls will take place after each dose and the gluten challenge.

Participants will also be asked to complete other activities (e.g., symptom diary, blood tests) to monitor symptoms and health. Compensation for time and travel may be available.

Qualifying for the trial does not guarantee that you will be enrolled in the trial. You are not required to participate if you qualify. Participation is voluntary; you can change your mind and withdraw from the study at any time.

Additional information about the AVALON trial may be found at ClinicalTrials.gov (NCT06310291)

Learn more about the AVALON trial and to see if you may qualify.