Therapy Areas: Autoimmune
First Patient Dosed in Phase 2 Trial of Therapeutic Vaccine for Celiac Disease
28 September 2018 - - The first patient has been dosed in US-based clinical stage company ImmusanT, Inc.'s Phase 2 RESET CeD trial for the treatment of celiac disease, the company said.

The trial will evaluate the safety and efficacy of Nexvax2, the company's lead investigational therapeutic vaccine in celiac disease patients who carry the immune recognition genes for HLA-DQ2.5, a subset that accounts for approximately 90% of those living with the disease.

This Phase 2 study will build upon previous Phase 1 results that have shown Nexvax2 to be safe and tolerable at its highest dose levels following stepwise up-dosing.

By further testing Nexvax2 at therapeutically-relevant dose levels, the company believes the findings will be significant in advancing the understanding of the potential impact of peptide-based immunotherapies.

RESET CeD intends to enroll approximately 150 patients across the United States, Australia and New Zealand.

Along with Nexvax2, ImmusanT is developing vaccines for other HLA-associated autoimmune diseases, including type 1 diabetes.

RESET CeD is a Phase 2, randomised, double-blind, placebo-controlled clinical study of Nexvax2, in adult subjects with confirmed celiac disease who have been following a gluten free diet for at least 12 consecutive months prior to screening.

This study will evaluate the efficacy of Nexvax2 administered subcutaneously.

The study plan consists of three periods: a screening period of six weeks, an approximately 16 week treatment period, and a four week post-treatment observational follow-up.

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

When a person with celiac disease consumes gluten proteins in wheat, rye and barley, the individual's 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 its ability to absorb nutrients into the body.

Celiac disease is becoming increasingly prevalent, and it is estimated that the disease currently affects 2 to 3m Americans and an estimated 1% of the global population.

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.

While GFD reduces intestinal inflammation, even minute amounts of gluten can still trigger an immune reaction with symptoms that can be more pronounced than before GFD was adopted.

GFD also imposes a significant burden, negatively affects quality of life, and can be difficult to follow since even minute amounts can trigger an immune reaction.

Nexvax2 is the most advanced therapeutic approach for celiac disease in clinical development TODAY that targets the fundamental cause of the disease.

It is an epitope-specific immuno-therapy, a class of therapeutic vaccine, that reprograms the T-cells responsible for celiac disease to stop triggering a pro-inflammatory response.

Nexvax2 is composed of peptides that include the epitopes most commonly recognized by T cells responsible for celiac disease. Nexvax2 intends to protect patients with celiac disease against inadvertent exposure to gluten.

ImmusanT is developing a new class of therapeutic vaccines to change the lives of people living with autoimmune diseases.

The company's Epitope-Specific Immuno-Therapy platform provides a precision medicine approach to restoring immune tolerance across a range of diseases, including celiac disease and type 1 diabetes.

Its lead programme, Nexvax2, is in clinical development with the goal of protecting celiac disease patients against the debilitating effects of gluten. 
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