July 2019

Note from Alice: Don’t Be Discouraged

Dear Beyond Celiac Community,

Many of you have asked me about the news that ImmusanT has discontinued its clinical trial investigating the Nexvax2 vaccine. My response to everyone is the same – don’t be discouraged. Don’t give up on the possibility we will eventually have better options than the gluten-free diet alone. Don’t give up on a cure.

As much as we’d like research into new treatments for celiac disease to be a straight shot from start to finish in record time, it rarely happens. Scientific discovery is usually a slow, incremental process, with successes and failures both building on each other to create a complete picture of how a disease can be treated and hopefully cured.

Most in the celiac disease research community, including scientists working on competing new treatments, were disappointed by news of the failure of Nexvax2 to suppress the immune response to gluten and consequently the effects of celiac disease. But they also quickly pointed out that a lot is learned from trials with negative outcomes, that the point of clinical trials is to thoroughly investigate what works and what doesn’t and that there are a number of promising different approaches in the celiac disease drug pipeline. One drug has even beaten the odds and made it to Phase 3 of clinical trial.

Additionally, the scientific world is looking at celiac disease as part of the broader autoimmune disease world, and progress is being made as a result. Those who study immunological diseases around the world have a growing interest in celiac disease. At Beyond Celiac, we remain committed to our mission of advancing research and supporting scientists even in the face of setbacks. We will soon announce the recipients of two new Beyond Celiac research grants.

Perhaps most important to mention is the patients who volunteered for the Nexvax2 trial, as well as all those who have participated in any other celiac disease study. ImmusanT helped protect the wellbeing of the study participants by ending the trial early after results showed they were not getting any benefit from the drug compared to the placebo. I personally want to thank the Nexvax2 participants for stepping up. And I want to encourage others to continue to volunteer and not let the outcome of this trial dissuade you. Be reassured that drug developers do take the steps needed to minimize risk and remember that research cannot progress without patient participation.

I also want to thank ImmusanT for pursuing a treatment for celiac disease with such dedication and care. The investment the company has made through its scientific, regulatory and business knowledge, as well as funding, is hard to describe or comprehend. We don’t yet know what the future holds, but we can only praise all the work that has been done in the past.

To keep this in perspective, think of the best way to respond to setbacks in your own life. If your child fails a test, if a project at work isn’t going well, if you try a difficult career change, if you have a fight with a friend, you most likely don’t throw your hands in the air and give up. You learn from your experience and move forward. That’s what happens in the research community, too. ImmusanT is looking at the trial results to better understand the outcome and will share what it learns. And we’ll all be a little closer to treatment choices beyond the gluten-free diet for celiac disease patients in the end.

To Living Life Beyond Celiac,

Alice