World’s first celiac vaccine enters international Phase 2 trial

07 Nov 2018 --- The world's first vaccine for people who have celiac disease is to be rolled out in an international trial. If successful, the vaccine, Nexvax2, would be the first medicine of its kind for people with the disease. Currently, following a gluten-free diet is the only treatment, but even the most diligent patients can suffer the adverse effects of accidental exposure. Therefore, the results of the vaccine’s trial may be eagerly awaited by those avoiding gluten due to their celiac condition.

This study will test if Nexvax2 can specifically target the immune response to gluten in people with celiac disease and modify the associated symptoms. Enrollment for the trial in Australia has begun before it will move to New Zealand and some US locations. Completion of the trial is expected in the second half of 2019, NutritionInsight has learned.

“Our current objective is to advance Nexvax2 through clinical development with the goal of potentially bringing to market the world’s first disease-modifying therapy for patients with celiac disease. If approved, our goal will be to bring this vaccine to everyone who needs it,” Leslie Williams, Chief Executive Officer of ImmusanT, a clinical-stage company leveraging its Epitope-Specific Immuno-Therapy (ESIT) platform for the trial, tells NutritionInsight.

“Inadvertent gluten exposures can cause significant and long-term negative impacts on patient health. At ImmusanT, we are deeply committed to advancing Nexvax2 to protect celiac patients from the effects of this exposure,” she adds.

Nexvax2 has successfully moved into a Phase 2 clinical trial following prior Phase 1 studies that proved it was safe and well tolerated at high dose levels.

Thousands of Australians have been awaiting this announcement, says Michael Bell, President of Coeliac Australia.

ImmusanT is also working to advance therapeutically and diagnostically for other types of autoimmune disease, including Type 1 diabetes, lupus, multiple sclerosis and rheumatoid arthritis.

“With the learnings from Nexvax2, we are translating and applying this knowledge to additional autoimmune conditions,” Williams tells NutritionInsight.

What is celiac disease?
Awareness around celiac disease is growing and it is estimated that the disease currently affects 2 to 3 million Americans and an estimated 1 percent of the global population.

It is a T-cell-mediated, chronic inflammatory disease of the intestine caused by an autoimmune-like reaction to dietary gluten proteins in genetically susceptible individuals.

When a person with celiac disease consumes gluten proteins in wheat, rye and barley, their immune system responds inappropriately by triggering T-cells specific for select epitopes (peptides) to fight the offending proteins (antigens), causing immune activation and acute digestive symptoms.

Ultimately, this reaction to ongoing gluten exposure causes chronic inflammation of the small intestine and compromises the body’s ability to absorb nutrients.

With rapidly increasing numbers of patients being diagnosed with the disease, there is a growing need for improved treatments. The only intervention currently available is a strict, lifelong gluten-free diet (GFD).

However, following a gluten-free diet can be complex and not always effective. Even the most diligent patients can suffer the adverse effects of accidental exposure.

While a gluten-free diet reduces intestinal inflammation, even minute amounts of gluten can trigger an immune reaction with symptoms that can be more pronounced than before GFD was adopted. GFD also imposes a significant burden, sometimes negatively affecting the quality of life as it can be difficult to follow since even minute amounts can trigger an immune reaction.

Although only 1 percent of the global population, gluten-free options in food and beverages are on the rise. In fact, the gluten-free food market is estimated to grow to US$7.59 billion by 2020 in the US, primarily driven by the increasing numbers of people who choose to eat gluten-free products but do not have gluten-related medical conditions: These consumers report feeling better by consuming less gluten, pointing to the huge market potential of reduced gluten products.

By Laxmi Haigh