World’s first celiac vaccine gains FDA fast-track designation during Phase 2 trial

03 Jan 2019 --- The world's first vaccine for people who have celiac disease, Nexvax2 from ImmusanT, Inc, has secured fast-track designation from the US Food and Drug Administration (FDA). The global Phase 2 study assessing Nexvax2 is currently recruiting patients, after rolling out late in 2018. Completion of the trial is expected in the second half of 2019. 

The FDA grants fast-track status to certain investigational drugs to expedite the development and review process for therapeutic candidates with the potential to fulfill the unmet needs of patients with serious or life-threatening conditions.

“We view the fast track designation for our lead candidate, Nexvax2, as a testament to the significant need for bringing therapeutic solutions to patients with celiac disease as quickly as possible,” says Leslie Williams, Chief Executive officer for ImmusanT. 

“Currently, there are no disease-modifying therapies for this condition, and the only solution for patients is strict adherence to a lifelong, gluten-free diet. Our hope is that by helping restore immune tolerance towards gluten, Nexvax2 will improve quality of life and prevent the serious complications of chronic gluten exposure in celiac disease patients. The development of Nexvax2 aligns with our strategic vision of transforming how patients with autoimmune diseases are treated,” she explains.

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

Thousands of Australians had been awaiting the announcement, Michael Bell, President of Coeliac Australia, said at the roll-out of Phase 2.

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?
“Celiac disease is a life-changing condition that causes significant health problems due to cumulative damage from chronic and repetitive bouts of gluten-triggered inflammation. In earlier Phase 1 studies assessing Nexvax2, a relationship between dosing schedule, pharmacokinetics and systemic biomarkers as a pharmacodynamic readout in ESIT was demonstrated for the first time,” says Ken Truitt, M.D., Chief Medical Officer for ImmusanT.

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.