PHILADELPHIA, July 2, 2024
/PRNewswire/ -- The Beyond Celiac Coalition, a precompetitive
partnership of multidisciplinary stakeholders involved in the
development of potential treatments for celiac disease, met
recently with the FDA to discuss a collaborative approach to making
therapeutic trials for celiac disease more patient-centric while
maintaining scientific rigor.
Participating in clinical trials is necessary to accelerate
research for treatment breakthroughs and a cure. Yet clinical
trials for celiac disease often struggle because currently most
studies require participants to undergo procedures or activities
deemed too invasive or debilitating by many patients.
"This was a pivotal meeting because key stakeholders heard
directly from people living with celiac disease about how the
disease and the gluten-free diet affect their quality of life,"
Alice Bast, Founder and CEO of
Beyond Celiac, says.
Another key discussion point was about the use of gluten in
clinical trials. "It will be difficult to get a drug approved
without introducing patients to gluten in clinical trials. However,
we recognize that this is a burden for clinical trial participants.
There is no one right way to use gluten in clinical trials. It was
educational for everyone to hear many perspectives on this topic,"
said Debra Silberg, MD, PhD, Chief
Scientific Officer at Beyond Celiac.
This was the first time the Beyond Celiac Coalition convened all
stakeholders including patients to meet with FDA representatives to
discuss the seriousness of celiac disease and the goals for
therapies. The purpose of the Beyond Celiac Coalition is to bring
together members from the pharmaceutical and biotech industry;
academic researchers and clinicians; and gastrointestinal
professional societies to identify and address significant barriers
to developing treatments for celiac disease.
Beyond Celiac Coalition patient organization and professional
society members include the American Gastroenterological
Association, Beyond Celiac and the North American Society for
Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN).
Academic and clinician members include Robert P. Anderson, MD; Lisa Fahey, MD; Edwin
Liu, MD; Joseph A. Murray,
MD; Marie Robert, MD; Jocelyn Silvester, MD, PhD; Marisa Stahl, MD, and Adam C. Stein, MD. The industry members are
Anokion, Chugai Pharmaceutical Co, Sanofi, Takeda Pharmaceuticals
and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd.
Although celiac disease is a common disease with a significant
unmet need, there is no medical treatment or cure. Following a
strict gluten-free diet is the only way the 3.2 million Americans
with celiac disease can control it. However, many people get
inadvertent exposure to gluten even if they are very careful. "If
more Americans understood how dangerous gluten can be for a person
with celiac disease, it would be a big step forward for those with
celiac disease to be able to eat without fear of unknowingly eating
gluten," Bast adds.
About Beyond Celiac
Founded in 2003, Beyond Celiac is
the leading catalyst for a celiac disease cure in the United States, serving as a patient
advocacy and research-driven organization working to drive
diagnosis and accelerate the discovery of new treatments. By
engaging with the top scientists in the field, making the right
investments in research and supporting the broad community of those
with celiac disease and gluten sensitivity, Beyond Celiac envisions
a world in which people can live healthy lives and eat without fear
– a world Beyond Celiac. BeyondCeliac.org
Media Contact:
Juliann
Kaiser, 770.643.1807
jkaiser@kaisermarketinggroup.com
Angela Crist, 419.306.4770
acrist@beyondceliac.org
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SOURCE Beyond Celiac