January 15, 2019

Nexvax2 now in Stage 2 Trials

Good news for Celiacs! On January 2nd, ImmusanT secured a fast-track for it's Nexvax2 as a vaccine for people with celiac disease. It's currently in Phase 2 of testing.

The FDA only grants fast track status to certain drugs when there is an unmet need for medicine with serious or life-threatening conditions.

"Nexvax2 will improve quality of life and prevent the serious complications of chronic gluten exposure in celiac disease patients. The development of Nexvax2 aligns with our strategic vision of transforming how patients with autoimmune diseases are treated.” - Leslie Williams CEO of ImmusanT in a recent press release

Fast Track to stage two testing does not increase the chances the drug will be approved, it's just a way that the FDA to move the drug along the process quicker.

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About the Phase 2 of the Trial

A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2. This study will evaluate 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.

Be Part of the Trial

To be considered for the trial you must be:

  • Someone who has been diagnosed celiac disease,
  • Must be over 18 and under 70.
  • Must be gluten free for at least one year.
  • HLA DQ 2.5 Positive
  • Participants must be willing to consume some gluten.

Unfortunately my 8-year-old daughter is not eligible for the study. If the trial is successful, hopefully, they come up with a children's version.

If you meet the simple criteria, why not be part of the study? On the Clinical Trial page is the locations where the trials are occurring. Simply contact the person nearest to you.

Oddly enough there is no trial in Massachusetts, which is the location of ImmusanT.

Estimated Completion Date

The trial will end on September 2019.

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