Barinthus Biotherapeutics Plc ((BRNS)) announced an update on their ongoing clinical study.
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Barinthus Biotherapeutics Plc is conducting a Phase 1 clinical trial titled ‘A Phase 1, First in Human, Randomized, Placebo-controlled Trial With a Controlled Gluten Challenge to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VTP-1000 in Adults With Celiac Disease.’ The study aims to assess the safety and tolerability of VTP-1000, a novel treatment for celiac disease, by evaluating its effects on the immune system when administered at various doses.
The intervention being tested is VTP-1000, a biological treatment delivered via intramuscular injection. It consists of self-assembling nanoparticles of gluten peptides combined with a rapamycin component, designed to modulate the immune response in celiac disease patients.
The study design is interventional, with participants randomly assigned to receive either VTP-1000 or a placebo. It follows a sequential intervention model, with both single ascending dose (SAD) and multiple ascending dose (MAD) formats. The trial employs quadruple masking, ensuring that participants, care providers, investigators, and outcomes assessors are blinded to the treatment allocation. The primary purpose of the study is treatment-focused.
The study began on February 16, 2024, with an estimated primary completion date yet to be announced. The latest update was submitted on August 22, 2025. These dates are crucial for tracking the study’s progress and anticipating future developments.
This clinical trial update could positively influence Barinthus Biotherapeutics’ stock performance by demonstrating progress in developing a potentially groundbreaking treatment for celiac disease. Investors may view this as a promising step forward, especially given the lack of effective treatments currently available. The outcome of this study could also impact competitors in the biotherapeutics industry, particularly those focusing on autoimmune diseases.
The study is currently ongoing, with further details available on the ClinicalTrials portal.