• by imatthews
  • onMay 19, 2019
  • 0 Comments

The US FDA Puts a Celiac Vaccine on the Fast Track & You Can Join the Trial!

You might have heard about a vaccine for Celiac Disease but don’t have the details… and neither did we so I dug into it and here is what I found:

There is a vaccine already in human trials from Cambridge Massachusetts based ImmusanT:

“… We are developing a new class of therapeutic vaccines to change the lives of people living with autoimmune diseases. Our Epitope-Specific Immuno-Therapy™ (ESIT™) platform provides a precision medicine approach to restoring immune tolerance across a range of diseases, including celiac disease and type 1 diabetes. Our lead program, Nexvax2®, is in clinical development with the goal of protecting celiac disease patients against the debilitating effects of gluten.
SOURCE

They explain their concept quite well in this short video:

The problem is they have not release much information on it.   I read a number of speculatory comments on other websites which made me decide to contact ImmusanT directly.  After a few weeks of getting no-where I ended up with their PR firm which did provide some useful information:

  • Phase 1 human trials with about 150 people in Australia and the United States successfully wrapped up in the fall of 2018
  • Phase 2 human trials began in Australia and New Zealand in October 2018

We also learned:

“… the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s lead therapeutic candidate, Nexvax2, being developed to protect celiac disease

To accommodate this Fast Track approval ImmusanT is currently recruiting celiac patients for another trial:

“… randomized, 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 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up.
SOURCE

If you want more details or are interested in joining the celiac vaccine Nexvax2 trial, surf to www.clinicaltrials.gov.

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