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In 1796, Edward Jenner developed a treatment for smallpox that consisted of exposing humans to a different and less severe form of the virus. Ever since then, scientists have developed dozens of similar therapies. The ultimate purpose of a vaccine, as this method came to be known, is to trick the immune system by exposing it to harmless elements of a pathogen.

Nexpep, a biotechnology company based out of Melbourne, Australia, took this concept and applied it to celiac disease.

The potentially groundbreaking results? Nexvax – a vaccine for celiac disease.

Celiac disease is an autoimmune condition causing your immune system to recognize gluten as a foreign intruder. The resulting immunological response to gluten ingestion causes the symptoms we are all so familiar with.

Nexvax would expose the immune system to the three most harmful protein fragments in gluten in the absence of the molecule that triggers that immunological response. Repeated exposure through weekly or monthly injections over a period of time, it is thought, will desensitize the immune system in a way similar to allergy shots.

Nexvax focuses on the HLA-DQ2 haplotype (genetic sequence), which accounts for 90% of celiac cases. This means that it would not be effective for roughly 10% of celiacs who present the HLA-DQ8 haplotype.


A Big Step in the Right Direction


Nexvax successfully completed its Phase I clinical trials. Phase I trials are used to test human safety, and if a treatment is deemed as safe to humans in Phase I trials, it can proceed to Phase II.

After successfully completing these Phase I studies, Nexvax was acquired by Cambridge, Massachusetts-based ImmusanT, Inc., which is taking Nexvax into Phase II clinical trials. Nexvax2, the newest form of the therapy, will be tested for its actual effectiveness in humans with celiac disease in these Phase II studies.

ImmusanT has raised some money for this promising new approach to a cure for celiac disease, but we can’t get our hopes up yet. Less than one third of pharmaceutical drugs survive Phase II trials and make it to Phase III. If Nexvax2 does make it to Phase III, it will mean that it has shown significant potential to be an effective treatment, and the studies will be widened to thousands of celiac patients.

Nexvax2 offers the most promise for a cure for celiac disease in the short-term. However, there are other treatments under development that would act in a different way.

Many of us have lactose intolerant friends who can simply take a Lactaid pill with their dairy products to mitigate or even eliminate adverse symptoms. Is a similar pill coming to us with celiac disease?

I’ll talk about that in the next installment of Celiac Disease and the Quest for a Cure.


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