FDA Fast Tracks Therapy That Could Help Celiac Disease Patients Tolerate Gluten

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in Celiac, News
Published: January 16, 2019
Photo: Getty

The FDA has granted fast-track status to a promising vaccine intended to help celiac patients tolerate some gluten exposure, which might accidentally occur when dining out.

Developed by Massachusetts biotechnology company ImmusanT, NexVax2 is an injectable immunotherapy that reduces patients’ immune response to gluten proteins by reprograming the T-cells that cause an autoimmune attack on the body. The principle of the vaccine is similar to that of allergy shots, in which injections promote tolerance.

NexVax2 was created to protect patients with the HLA-DQ2.5 immune recognition genes when they experience accidental gluten ingestion. More than 90 percent of celiac patients carry these genes.

Although several drug options are under study, currently celiac disease patients have just one option when it comes to treatment: stick to a strict gluten-free diet or suffer the sometimes agonizing consequences. The FDA’s fast-track designation is intended to accelerate the development of crucial therapies and drugs.

Other experimental celiac therapies have also received this FDA designation, including Innovate Biopharmaceuticals’s larazotide acetate (in Phase 3 trials), ImmunogenX’s latiglutenase and Cour Pharmaceuticals’s TIMP-GLIA.

With Nexvax2, patients receive a small amount of the vaccine to start, with the dose gradually increasing. “Over time, the immune system of patients treated with Nexvax2 learns not to respond to small amounts of gluten,” Leslie Williams, ImmusanT CEO, told Allergic Living. She says that by reducing the immune response, Nexvax2 is meant to protect celiac patients from immediate symptoms, such as abdominal pain or diarrhea, nausea, as well as chronic medical issues such as malnutrition, anemia and osteoporosis.

ImmusanT is recruiting for a Phase 2 trial of NexVax2, involving 150 patients from the U.S., Australia and New Zealand. As patients are given weekly injections, the researchers will track the effectiveness and durability of their responses to the vaccine.

“Our goal is to advance Nexvax2 as fast as possible and to bring this potentially life-changing therapy to all people suffering from celiac disease,” says Williams.

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