Barinthus Bio Reports Positive Phase 1 AVALON Results For VTP-1000 In Celiac Disease, Showing Strong Safety And Dose-Dependent Effects

Barinthus Biotherapeutics plc, an immunology and inflammation company developing immune tolerance therapies with potential to offer long-term disease control, announced an update from its first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease. In the single ascending dose (SAD) portion of the study, VTP-1000 was well tolerated with no treatment-related serious adverse events, and researchers observed a clear dose-dependent pharmacological effect. The multiple ascending dose (MAD) portion of the trial, which includes a gluten challenge, is currently in progress, and results are expected in the second half of 2026.

The SAD stage of the AVALON Phase 1 trial (NCT06310291) enrolled 18 adults into three placebo-controlled dosing cohorts. Across all dose levels, VTP-1000 showed a favorable safety profile with no treatment-related serious adverse events. The pharmacology data collected during this stage also showed responses that increased with higher doses.

Dr. Leon Hooftman, Chief Medical Officer at Barinthus Bio, said he is encouraged by the results so far, noting that VTP-1000 represents the first antigen-specific immune tolerance therapy for celiac disease that employs an immunomodulator. He highlighted that the therapy was well tolerated at every dose, with no serious adverse events linked to treatment. He also explained that the IL-2 responses observed across all doses, combined with the strong safety data, indicate immune engagement without triggering significant inflammation. According to him, the dose-dependent pharmacological effects seen so far are promising, and the upcoming multiple-dose and immunological data will be important to determine optimal dosing and to better understand VTP-1000’s potential to modify the disease and improve outcomes for patients.

VTP-1000 is an investigational injectable therapy designed to induce antigen-specific tolerance. It uses Barinthus Bio’s proprietary SNAP-TI platform to deliver multiple gluten-derived peptide antigens—sourced from wheat, barley, and rye—together with the immunomodulator rapamycin, all packaged in nanoparticles meant to train the immune system to tolerate gluten.

Bill Enright, Chief Executive Officer of Barinthus Bio, said that the SAD results show that a single dose of VTP-1000 can trigger a targeted immune response that may help reduce adverse effects caused by gluten exposure in people with celiac disease. He added that the company plans to present detailed pharmacological and clinical data at a scientific conference in 2026.