With the 9 Meters decision to halt the CedLara Phase 3 trial because of the cost of patient recruitment, it is more imperative than ever that our celiac community comes together to enroll in clinical trials. The Celiac Disease Foundation has been demanding treatments primarily because up to 50% of all celiac patients report ongoing symptoms even when attempting to strictly adhere to a gluten-free diet. Despite this Phase 3 pause, we remain vigilant and hopeful as we continue to support a number of treatments in the pipeline for celiac disease.

The number of treatments, while encouraging, remains relatively small when compared to other diseases. Still, it is a glass half-full scenario. Central to the reasons that the research community is making so much progress is that the Celiac Disease Foundation launched a strategic effort more than a decade ago to minimize the barriers to development of a celiac disease drug. This includes:

1. Evidence of Need – Most researchers and biopharmaceutical companies believed that celiac disease was well-managed by the gluten-free diet; they did not understand how important it was to the celiac patient community to have a therapeutic adjunct to the diet and, therefore, that there was a market for a drug. Researchers using the iCureCeliac® patient registry established that nearly 50% of patients reported that strict adherence to a gluten-free diet was not adequately managing their symptoms and that they were not only suffering from a broad array of symptoms, but they were also missing, on average, 33 days annually from work or school.

2. Secure NIH Funding – The lack of federal funding for celiac disease research has long crippled the advancement of research in the field, which has, in turn, delayed investments into drug development. The dearth of NIH funding—indeed the refusal of virtually the entire federal health sector to take celiac disease seriously—meant that academic research labs, where much of the groundwork for drug development is done, looked to other diseases for better funding. The Celiac Disease Foundation has worked diligently with our advocacy team, including our network of Patient Advocates, to rally Congress over the last several years, which led to the first Notice of Special Interest (NOSI) issued by NIH last November. We see the NOSI as a down payment on NIH funding for celiac disease, an important start.

3. High Cost of Drug Development – A study published in the Journal of the American Medical Association in 2020 estimated that the median cost to bring a new drug to market was $985 million, and the average cost was $1.3 billion during the period 2009-2018. One of the biggest costs that drug developers must absorb is the extraordinary expense of recruiting and retaining patients for the multiple phases of clinical trials. The Celiac Disease Foundation, building on the strength of iCureCeliac®, the nation’s first and the world’s largest celiac patient registry, and iQualifyCeliac, the nation’s first study screening platform for celiac disease, has supported 24 studies and trials, with 5 more launching later this year, dramatically lowering costs for biopharmaceutical companies.

I cannot stress enough how important it is for the Celiac Disease Foundation to expand its efforts to educate qualified patients to consider participating in clinical trials. No drug can be approved without going through the rigorous, extensive safety and efficacy protocol established by the FDA. But, as you can imagine, finding adequate numbers of qualified patients can be a challenge, even for us. Patient requirements can differ between trials, and it is often the case that patients must live near a trial site.

As we have repeatedly demonstrated, the Celiac Disease Foundation is committed to leading the fight for our patient community to finally have access to therapies adjunctive to the gluten-free diet. This is why in July we are launching a major initiative across all our digital platforms to add 2,000 more patients nationwide to our patient registry, iCureCeliac®, the single best patient-centered resource for celiac disease researchers in the world. The campaign for iCureCeliac® features a new and compelling short film by filmmaker, Hayley Repton, that highlights the importance of participating in iCureCeliac®. We look forward to sharing this with you.

As always, your generous support makes our work possible. If you are in a position to give, please do.

To Our Health,

Marilyn G. Geller
Chief Executive