IBD Innovate 2021: Accelerating solutions for people with IBD

New solutions, innovative products, and precision medicine are all on the horizon for patients with inflammatory bowel disease (IBD). That’s the message that came through loud and clear at IBD Innovate 2021, the Crohn’s & Colitis Foundation’s flagship event that brings key stakeholders together to share ideas and highlight emerging advances in care for people with Crohn’s disease and ulcerative colitis.

Now in its fourth year, IBD Innovate builds on our IBD Ventures program. Since 2017, the Foundation has invested directly in technologies that promise to meet the strong demand for safe, effective care for the millions of people dealing with the physical, mental, emotional, and social challenges that accompany gastrointestinal conditions.

Following is a synopsis of what’s in the pipeline and how new products are being developed.

Better understanding for better care

Day One’s Keynote Address featured Nancy Thornberry, founding CEO of Kallyope, a New York City-based biotechnology company focused on unlocking gut-brain circuits to discover new drugs that address IBD issues.

The gut-brain axis provides a connection between the nervous system, different areas of the brain, and intestinal function. According to Thornberry, “The better we understand that connection, the better our chances of developing treatments that work.”

Kallyope uses numerous technologies to study and develop therapeutic solutions. The company has built a highly integrated technology platform for the discovery and translation of gut and gut-brain physiology and care.

They focus their energies on three main therapeutic categories:

•    Metabolic circuits to prompt weight loss in obese or Type 2 diabetes patients.
•    Gastrointestinal barrier program for gut barrier restoration relevant to IBD, food allergies, and gut injuries.
•    Inhibitors that protect neuronal (nerve) cells damage and will target Parkinson’s disease, neuroinflammation, and other central nervous system disorders.

Kallyope is currently pursuing multiple programs across several disease areas, including IBD.

New ways to reduce chronic inflammation and improve IBD symptoms

Researchers have long agreed that being able to repair disease or inflammation in the digestive tract lining (mucosal healing) could reduce IBD symptoms — providing significant relief and improved quality of life for patients.
It’s been an elusive target for investigators. No current medications directly target the biological processes involved in mucosal healing. And there are no universal guidelines or methods to assess mucosal healing, so it’s difficult to document when it’s achieved.

What’s more, the tests currently used to assess mucosal healing are often invasive, inconvenient, and uncomfortable for the patient.

Gerard Honig, director of research innovation at the Crohn’s & Colitis Foundation, led a panel to discuss some of the exciting advances under development. Honig announced a new collaboration dedicated to establishing a standard methodology for the measurement of mucosal healing, to be used in clinical trials of new potential treatments for ulcerative colitis. 

The project is a partnership between the Foundation for the National Institutes of Health (FNIH), the Foundation, and several private-sector and academic organizations. The Consortium will, for the first time, standardize universal guidelines to measure mucosal healing and establish a machine learning methodology for scoring healing in clinical trials and clinical practice, specifically for ulcerative colitis.

More information about the collaboration can be found here.

During the panel, researchers shared several advances for clinical care, including:
•    Developing therapeutic options for wound repair to fix damage inside the gastrointestinal system.
•    Using computer algorithms to make colonoscopies and endoscopies more accurate by identifying areas of concern earlier and more clearly.

New drug delivery technologies

Changing how a drug is delivered can be an effective way to improve its safety and efficacy. The second series of presentations at IBD Innovate 2021 centered on advances in drug delivery systems.

Innovative drug delivery systems that are currently under development include:
•    A smart capsule that uses light to navigate the patient’s gastrointestinal environment. When the capsule reaches the diseased area, it releases medication precisely to the area where it will be most effective.
•    A drug released slowly over time in a designated location inside the patient's intestine. The medication is delivered through an injection, allowing targeted placement instead of distribution throughout the body. The technology is being used to develop a novel therapy for strictures.
•    Oral medications that treat gastrointestinal inflammation by specifically targeting cells involved in the disease process.

Stakeholder panel: A personal story

Patient Dewey Thom shared his journey to diagnose and manage his Crohn's disease. Thom was diagnosed “after a struggle” when he was a teenager. At first, his pediatrician thought he just had a nervous stomach. Thom was eventually sent to a GI specialist who used “invasive, embarrassing, and difficult tests” to diagnose his condition. He later underwent J-Pouch surgery and has since been diagnosed with Crohn’s disease. 

Thom spoke of the challenges brought on by his condition. He has had trouble determining what treatment options will work long-term to alleviate his symptoms. He worries that treatment will lose effectiveness and quit working over time – requiring him to start over for a care regimen.

For Thom, the partnership he’s formed with his healthcare team is essential. He credits their collaboration as the key to success.

Day Two

Day Two started with an overview of the Crohn’s & Colitis Foundation. The organization was founded in 1967 to accelerate research and promote cures for Crohn's disease and ulcerative colitis. We work to develop and identify novel approaches that meet the unmet needs of patients with gastrointestinal conditions. Our ultimate goal is to improve the quality of life of children and adults affected by these chronic illnesses.

Ongoing programs of note include:
•    Crohn’s & Colitis Congress is scheduled for January 20-22, 2022, in Las Vegas. The event focuses on professional education and research.
•    IBD Ventures is the venture philanthropy branch that awards grants of up to $500,000 for selected projects.
•    IBD Plexus provides researchers with access to clinical and patient-reported data.

Big data for big results

Big data has the potential to improve treatment for IBD in ways that are still being explored. Big data in healthcare refers to huge amounts of information based on health data and molecular data from different patient populations. Information helps document and predict what works and what doesn’t. It lets researchers and care providers understand trends, predict behaviors, and learn specifics about disease and its effect on the body.

Big data sources include:
•    Electronic health records
•    Imaging technologies such as CT and MRI scans or GI ultrasound
•    High throughput molecular technologies such as genomics, proteomics, and metagenomics

Using big data for precision medicine applications in IBD has the potential to improve diagnosis, drug response prediction, and patient outcomes. Examples of innovations in big data that were highlighted include platforms, biobanks, and databases that contain information that enables targeted precision medicine for better, safer results.

Bringing innovation to patients

Day Two’s second session focused on advances in care to keep an eye on. Examples of what has researchers and investors excited include:
•    Risk assessment tools for use when determining medication and other care options
•    Medications that combine both proven and innovative new drug delivery systems

Journals and special publications

The Crohn's & Colitis Foundation published two journals and other special publications to promote understanding of IBD and best care practices. Journals contain articles on basic science, clinical, and transitional medicine. Their focus is improving knowledge and clinical care to produce better patient outcomes, improving their health and quality of life.

Publications include:
•    Inflammatory Bowel Disease® is the first journal dedicated exclusively to IBD. This specialized monthly journal covers topics of interest to the professional clinician or researcher.
•    Crohn’s & Colitis 360 is an open access, online-only journal. It features content that engages, informs and catalyzes dialogue on comprehensive care options for patients with IBD.
•    IBD Innovate Special Collection is a recently released special publication covering a wide range of topics. Articles cover multiple areas of interest, including a special companion issue focused on insights from the IBD Innovate conference series. 

The power and limits of artificial intelligence

The second keynote speaker, Regina Barzilay, Distinguished Professor of Machine Learning and Health, EECS, Massachusetts Institute of Technology (MIT), spoke about the power and limitations of using artificial intelligence to diagnose and treat chronic diseases.

Artificial intelligence (AI) and machine learning are often used to gain clinical insight to improve care options. All AI applications collect patient data and use it to make predictions about patient outcomes. Currently, AI is often used to diagnose conditions such as breast and lung cancer that benefit significantly from early detection.

AI has the potential to help reduce disparities in healthcare. A diverse population gives the most accurate results when collecting data. The ideal patient population for training AI models includes people of different ages, backgrounds, health histories, and other differentiators depending on the intended outcome. 

AI is used to:
•    Automate tasks humans can do, which is being done now.
•    Automate tasks humans cannot do, which is rising in significance.
•    Derive new insights, which is an emerging area.

AI is not foolproof. The technology faces several challenges, including:

•    AI is data hungry. Large amounts of data are needed to produce the best results. 
•    Data sharing requires tools to preserve patient confidentiality and privacy.
•    Acquiring enough data about rare diseases is difficult due to the small number of patients for whom relevant data is available.
•    The accuracy of the data is not always verified.

Machine learning can make predictions that are beyond the scope of human capabilities. The key to success is creating an environment where human doctors and AI tools come together to benefit the patient to provide safe, effective care.

Meeting unmet needs

There is currently no cure for IBD. Medications that are currently available may not be effective or lose their effectiveness over time. Testing is inadequate and does not always predict the response to treatment accurately.

The Crohn’s & Colitis Foundation is working to change that.