
Nexvax2 – promising vaccine to cure coeliac disease
The End of Gluten Free Diet?
Nexvax2 is promising vaccine to cure coeliac disease. It is currently the only vaccine in clinical trials with a high potential to actually cure coealiac disease (CD). To be clear it will cure the CD with a genotype form of haplotyte HLA-DQ2.5. About 80% – 90% of patients with coealiac disease have this genotype. To cure the CD thus means that patients become gluten tolerant again, without the need of any gluten free diet. This is really cool! The principle of the treatment is based on reprogramming T-Cells, the cells of the immune system, and their response to specific peptides of the gluten protein.
The very first phase of the clinical trial on a small scope of patients confirmed the positive effect and safety of the vaccine. Volunteers were vaccinated for a couple of months and then they could eat normally. The gluten free diet wasn’t followed. After a couple of months the effect was confirmed by the small intestine biopsy.
Thanks to the success of the first phase the clinical study continued to the second phase. The study in New Zealand is fittingly named Biscuit (Reset) Study. In this randomized phase of the study hundreds of volunteers in Australia, NZ and the US will be injected with placebo or vaccines twice a week for four months. Usually the second stage of clinical trials determines the medicine’s effect and safety using a larger sample of patients while lasting a couple of years. This will be followed by the third phase which will determine the medicine’s dosage. This phase could involve thousands of patients and is predicted to be the longest, 5 to 7 years.
Uncertainty
A lot of progress has been made in the research of biological treatments of autoimmune diseases. So the question is not “will the CD be treatable” but “when will the treatment be available” and “how much will it cost”.
Web Resources
New Zealand clinical trial – Biscuit (Reset) Study
Clinical trial in the US – A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
Pharmaceutical company ImmusanT
The vaccine that could end coeliac disease