FDA fast tracks celiac disease vaccine

January 4, 2019

FDA fast tracks celiac disease vaccine

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Designation highlights need for new treatments for patients

By Amy Ratner, Medical and Science News Analyst

A vaccine being studied to treat celiac disease has received fast-track designation from the U.S. Food and Drug Administration.

The designation is designed to speed the development and review process for drugs that have the potential to fulfill unmet needs of patients with serious or life-threatening conditions. Several other drugs being studied for the treatment of celiac disease – larazotide acetate by Innovate Biopharmaceuticals, latiglutenase by ImmunogenX and TIMP-GLIA by Cour Pharmaceuticals – were previously given FDA fast-track designations.

Even with fast-track designation, FDA drug approval is a lengthy process. FDA first fast tracked a celiac disease drug nearly seven years ago.

Read More: Drug pipeline charts progress of celiac disease treatments

Currently, there are no drugs available on the market to treat celiac disease. A lifelong gluten-free diet is the only way for patients to manage the disease, and research increasingly shows the diet is not the complete treatment it was once thought to be.

Nexvax2 is a therapeutic vaccine being investigated in a Phase 2 study, which is currently recruiting 150 patients in the United States, Australia and New Zealand for participation in a clinical trial. Nexvax2 is being developed to be used in addition to the gluten-free diet to provide protection from inadvertent gluten exposure, for example from cross-contact when dining out. Adult patients can find detailed information about participating in the clinical trial here.

Read more: How Nexvax2 would work

“We view the fast-track designation for Nexvax2 as a testament to the significant need for bringing therapeutic solutions to patients with celiac disease as quickly as possible,” said Leslie Williams, chief executive officer for ImmusanT, the Massachusetts biotechnology company developing the vaccine. “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.”

Nexvax2 is a form of immunotherapy, a promising approach to celiac disease that uses the body’s own immune system to treat or prevent disease. The premise behind Nexvax2 is that if a small amount of the vaccine is given at first and the amount gradually increased, the immune system of those who have celiac disease, and the HLA_DQ2.5gene most commonly associated with it, will build up resistance to the harmful protein in gluten without any negative effects.

As a therapeutic vaccine, Nexvax2 is designed to treat disease by targeting an immune response that is already occurring in those who have celiac disease. It would differ from a vaccine that works by preventing a disease, for example a flu vaccine, which produces a new immune response in the body.

Read More: Nexvax2 moves to important new phase of study

“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,” said Ken Truitt, M.D., chief medical officer for ImmusanT. “Using a novel panel of celiac disease-associated immunological markers, identified in early clinical studies, we can follow both acute symptoms and the underlying inflammatory response following gluten exposure. This helps monitor Nexvax2’s effectiveness in altering the disease process.”

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