INDIANAPOLIS—The Leona M. and Harry B. Helmsley Charitable Trust announced today it is awarding a grant to Indiana University’s School of Medicine to support a breakthrough study to inform evidence-based recommendations that could enhance the colonoscopy process for patients with Crohn’s disease. The grant, totaling $644,250, further advances Helmsley’s mission to improve the lives of people living with Crohn’s disease.
Patients with Crohn’s disease require frequent colonoscopies to enable screening for colorectal cancer and monitoring of disease activity. Current FDA-approved colon preps are poorly tolerated, and thwart adherence: they require fasting, the consumption of liters of salty, viscous liquid, and are often not completed – compounding the burden placed on patients, doctors, and the healthcare system. This burden is multiplied in patients with Crohn’s disease who typically need to undergo frequent procedures to monitor and treat disease activity. Bowel preps have been developed for the largely healthy population undergoing routine colon cancer screening: as many as 20 million colonoscopies are conducted each year in the US alone. But little is known about the specific needs and experience of patients with Crohn’s disease undergoing bowel prep for colonoscopy, and innovation is scant.
The “Development of a regulatory roadmap for colonoscopy bowel preparations for Crohn's Disease patients” study is a collaborative effort between multidisciplinary experts from Indiana University’s School of Medicine, ColonaryConcepts, LLC, a gastrointestinal health focused drug development enterprise, and Alimentiv, a leading gastrointestinal contract research organization.
The study initially focuses on characterizing the current Crohn’s disease patient and medical provider experience, identifying barriers to effective treatment. It will then propose a roadmap for bringing a bowel preparation through the regulatory pathway and ultimately to market. This includes designing a pivotal, Phase 3 study comprising patients with Crohn’s disease that will incorporate ColonaryConcepts’ innovative new ECP colon prep drug candidate, a patient-friendly, split-dose prep kit that features palatable food bars and low-volume beverages. The study will likely also incorporate a novel scoring methodology for judging the efficacy of any colonoscopy preparation in patients with Crohn’s disease.
“Patients with Crohn’s disease and their providers face unique challenges with their required, frequent colonoscopies. We need to better understand these challenges so that we can optimize the bowel preparation process and their overall colonoscopy experiences,” comments Principal Investigator Jennifer Maratt, MD, MS, Assistant Professor of Medicine at Indiana University (IU) School of Medicine. “This grant will enable us to convene a team of world-class experts in Crohn’s disease, colonoscopy and bowel prep, clinical program design, regulatory pathway management, clinical study biostatistics, and pharmaceutical product development.” Dr. Maratt will be joined in this program by Douglas Rex, MD, Distinguished Professor Emeritus of Medicine at IU School of Medicine and Director of Endoscopy.
“Improving the lives of people living with Crohn’s disease is a priority for the Helmsley Charitable Trust,” said Pretima Persad, a Helmsley Program Officer. “In 2021, we know that a better colonoscopy experience is possible, especially for those who require frequent procedures. We are grateful that this team of researchers shares our vision.”
Adds Corey Siegel, MD, Director of the Inflammatory Bowel Disease (IBD) Center at the Dartmouth-Hitchcock Medical Center, Professor of Medicine at Dartmouth Medical School, “we’re thrilled to tackle this understudied – yet critical – dimension of Crohn’s disease care. Ultimately, we aim to provide patients with Crohn’s disease and their caregivers with better options to monitor and manage their disease states.”
Comments Joshua Korzenik, MD, Director of Brigham and Women’s Hospital Crohn’s and Colitis Center, and Assistant Professor at Harvard Medical School, “We’re excited to develop a roadmap for a Crohn’s-patient-specific bowel prep that provides practitioners and researchers with new insights to support better, targeted diagnostics and care for patients with Crohn’s disease.” He adds, “ultimately, we also hope to catalyze more interest in patients with Crohn’s disease by the pharmaceutical industry, and more innovation in bowel preps.”
Both Dr. Siegel and Dr. Korzenik are specialists in Crohn’s disease, and are co-founders of ColonaryConcepts, LLC.
About IU School of Medicine
IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.
About the Helmsley Charitable Trust
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has committed more than $3 billion for a wide range of charitable purposes. Helmsley's Crohn's Disease Program supports impactful ideas and mobilizes a global community committed to improving the lives of Crohn's disease patients while pursuing a cure.