ImmunsanT has announced that it is ending its global Phase 2 RESET CeD clinical trial for its Nexvax2 drug candidate. Early results indicate that the drug, which is designed to protect celiac disease patients from gluten exposure, worked no better than a placebo. This news comes as a surprise and disappointment to everyone in the celiac disease community.
There is overwhelming evidence that the gluten-free diet doesn’t work well enough, if at all, for millions of celiac disease patients. The hope was that Nexvax2 would be a therapeutic backstop for some of these patients.
You can read ImmunsanT’s announcement about discontinuing the clinical trial here.
Leslie Williams, President and CEO of ImmusanT, and her entire team, have worked tirelessly on Nexvax2 research. They understand the limitations of the gluten-free diet and the suffering so many in our community must endure, and believed that they had found an intervention that could offer some much-needed relief. We thank them for their effort. As many of you know, Ms. Williams provided testimony for the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies that resulted in report language about celiac disease research in the NIH appropriations bill. She is committed to our cause to accelerate diagnosis, treatments, and a cure.
We also want to thank everyone in our community who participated in the trial, as well as everyone who used our iQualifyCeliac tool to see if they were eligible to participate. Your contributions are invaluable, and we hope that we can count on your sustained support in the weeks and months ahead.
Drug development is both expensive and risky…and it is becoming more so. The failure of ImmusanT’s Nexvax2 after the investment of tens of millions of dollars brings that point home. Deloitte, a large professional services firm, reported in December 2018 that projected returns in pharmaceutical research and development for the top 12 pharmaceutical firms have fallen to 1.9%, the lowest level in nine years, and that the average cost of developing a drug has almost doubled since 2010 to $2.18 billion. The good news is that there are a number of celiac disease drugs that are still in the pipeline, and we are hopeful that some of these will emerge and secure FDA approval. But this a long, tough, and expensive journey.
At the Celiac Disease Foundation, we have committed to doing everything we can to lower the cost and the risks inherent in the drug development pipeline. Our work is even more significant because we have never had an FDA-approved celiac disease drug that investors can point to and use as a benchmark. This is what we are doing to help bring a celiac disease drug to market in the near term:
- Direct investment in research. As evidenced by our most recent $325,650 Young Investigator Research Grant Awards—as well as our smaller investments in innovative projects like the Technion and Teva Pharmaceutical hackathon to develop a smart tool for the early detection of celiac disease—Celiac Disease Foundation philanthropy drives basic scientific research, epidemiology studies, and the improvement of diagnostic tools. Failures like Nexvax2 in unproven markets like celiac disease make investors skittish. We don’t view celiac disease the way venture capitalists do. Our goal is to end the suffering caused by celiac disease, a priority that demands that we take greater risks. Our research investments are essential to help fill gaps in critical areas.
- iCureCeliac® and iQualifyCeliac promote efficiency. These two Celiac Disease Foundation tools lower the cost of research and development by providing data to support what patients need and want, and by efficiently supplying qualified patients to studies and clinical trials to assess the efficacy and safety of potential diagnostic tools and therapeutics.
- Advocacy. It can be argued that the single biggest reason that celiac disease has no approved therapies, despite the fact that nearly 1% of the American public have the disease, is the almost total neglect of celiac disease by the National Institutes of Health, the world’s premier biomedical research agency, and other government agencies. Thanks to our efforts this neglect may soon come to an end, and celiac disease research will finally benefit from NIH investments at levels commensurate with the burden caused by the disease.
We are deeply disappointed by the news from ImmusanT. What this failure illustrates, however, is the critical role philanthropy must play to bring therapies that will improve the quality of patient’s lives through the drug pipeline, to FDA-approval, and into pharmacies.
Thank you for contributing to our efforts.
Want to take immediate action? Add your data to our iCureCeliac® patient registry today. iCureCeliac® is a free online portal for patients, or their caregivers, to provide critical insights into life with celiac disease. Your participation will help create better diagnostic tools and treatments for cross-contact and gluten consumption, governmental policy changes, and access to new and innovative clinical trials nationwide, which may, one day, cure celiac disease.