2020 Impact Report: Achievement in the Face of Adversity
Despite the challenges of the pandemic, we remained laser-focused on supporting IBD patients and made extraordinary progress in research.
Message from Our Leadership
Eyes on the Prize
We entered 2020 with great plans and optimism, but in March, along with the rest of the world, our plans changed drastically. The onset and rapid spread of COVID-19 completely changed the trajectory of everyday life, including how we travel, socialize, and conduct business. But while we were faced with many challenges, we also had some amazing achievements despite this unprecedented adversity. With the help of so many members of our community, the Foundation quickly adapted and found new ways to educate and support patients and providers, continued to advance research for cures, and raised critical funds to keep our mission moving forward.
We rapidly developed new resources and became the hub of information about COVID-19 and IBD, working with IBD experts across the country to develop up-to-date website content, host live video chats, share patient experiences, and, importantly, to continually update all resources as new information emerged. Our COVID-19 resources reached over 1 million people in 2020, and we are still updating them, as the virus continues to impact our country and our community. Yet, this was not our sole focus by any means.
As we adjusted to our challenging new reality, we remained intently focused on our mission, through advancing groundbreaking research designed to help find new treatments and cures for IBD, and by developing a number of new educational materials:
- We launched an extensive IBD-focused precision nutrition effort to better understand the direct impact that diet may have in the management of IBD. We began a partnership with LifeArc, a venture philanthropy organization, to develop the first-ever clinical lab blood test designed to predict disease course in children with Crohn’s.
- We supported the development of a new first-in-class oral therapy to treat IBD by supporting tissue repair.
- We expanded IBD Qorus, our quality-of-care initiative, to 55 sites nationwide.
- We launched new materials on important topics in IBD, including effective patient-provider partnering (treat-to-target), complementary medicine, and pain and fatigue.
And of course, we successfully migrated our staff to remote work, and moved our support groups, educational programs, and Camp Oasis to online experiences—all while maintaining a remarkable level of engagement with our entire community.
In addition to the economic and health problems we experienced as a result of the pandemic, systemic racism also moved into the forefront in our country. In 2020, we doubled down on our efforts to ensure equal representation among our staff, board members, and members of our National Scientific Advisory Committee. And we reinforced our commitment to understanding the impact of IBD on racially and ethnically diverse communities and engaging these communities in the development of all our programs going forward.
Importantly, we also developed a new four-year strategic plan in 2020, which is available on our website. We engaged many members of our community in this process, and the main sections of this Impact Report highlight the key areas that the plan will focus on as we move forward toward our vision of a world free from IBD.
- On the mission side, we are taking on critical challenges such as improving remission rates, increasing access to care, and advancing new therapies and innovative products.
- On the revenue side, with the help of our community, we are committed to becoming a $100 million organization by 2024; we must grow our revenue to effectively fund our mission.
We made incredible progress in 2020, despite the challenges we faced, and that is because of each one of you. You showed generosity in innumerable ways, and we are incredibly humbled and grateful for your unwavering support. We have some big goals for 2021 and beyond, but we know with your support, we can achieve anything.
Engaging Patients & Caregivers
We bring together the largest IBD community in the country, inspiring them to join our mission to find cures.
Support in the Time of COVID-19
In 2020, change was a constant. So, too, was the Crohn’s & Colitis Foundation, which continued to provide reliable, practical support tailored to the needs of people with inflammatory bowel disease (IBD).
“We became the hub of COVID-19 IBD expertise,” says Laura Wingate, the Foundation’s senior vice president for education, support, and advocacy. “We quickly responded to our patients and physicians by providing education and resources to supply the critical information they needed, all in a virtual setting.”
Early components on our site included scientifically accurate information about SARS-CoV2, the virus that causes COVID-19, as well as practical tips such as how to combat loneliness while keeping socially distant. As the pandemic continued, our site expanded to include information about clinical trials to test emerging coronavirus treatments, the vaccine rollout, and guidance for children with IBD. During Facebook Live education events (the videos are archived for access at any time), physicians and patients discussed the latest information about COVID-19 and IBD, strategies for managing the emotional and mental health toll of living through a pandemic, and questions and concerns IBD patients have had about vaccination.
The effort was comprehensive and ongoing. Through these programs, we made over 1 million connections with our patients, caregivers, and professionals worldwide. Says Wingate: “An army of doctors, nurses, psychologists, and patient leaders came together to identify needs, build, and share our resources to get information out to the community.”
Celebrities Speak Out
“My mother has suffered with Crohn’s for over four decades.”
“My mother has suffered with Crohn’s for over four decades. I admire her so much, and I was pleased
be able to show my support for the Crohn’s & Colitis Foundation. I sincerely hope a cure for Crohn’s
colitis is in the future.”
Virtual Connection, Real World Impact
Like many kids who’ve been struggling with virtual schooling, nine-year-old Ryan says that Zoom meetings tend to be boring. Yet she found the virtual Camp Oasis experience so compelling she didn’t mind having to connect to her counselors and other campers through a mix of video calls and online events.
Camp Oasis, the Crohn’s & Colitis Foundation’s summer camp for kids with IBD, is typically a weeklong residential experience. The pandemic, of course, changed that. Rather than cancel the much-loved program for 2020, the Foundation decided to take it virtual. More than 1,300 campers participated; 455 were first-timers, like Ryan.
Before camp started, everyone received a “Camp-in-a-Box” package of arts and crafts supplies, Camp Oasis swag, and program materials. Most of the activities were go-at-your-own pace: Ryan planted flower seeds to attract butterflies (in a pot she painted hot pink) and made a friendship bracelet. But she especially enjoyed the opportunity to get to know her fellow campers during “cabin chats.”
“When people look at me, they see a normal girl, but inside I’m different,” says Ryan. “It was nice to hear someone else say, ‘Oh, I know that medicine. I took it and then I got better.’”
Ryan’s mom, Marcal, says she was thrilled her daughter had the opportunity to connect with other kids who really understand what she’s going through, noting that their Los Angeles–based family doesn’t know any other children with IBD. “I think for the first time since her diagnosis in March 2019, Ryan didn’t feel alone.”
This coming summer, Ryan hopes to be able to attend Camp Oasis again. “It’s a great camp,” she says. “It feels good to fit in.”
Getting the Inside Scoop on IBD Research
The Crohn’s & Colitis Congress® (Congress), an annual event organized by the Foundation in partnership with the American Gastroenterological Association (AGA), connects clinicians, researchers, and other IBD thought leaders from around the world. While this premier event is primarily aimed at professionals, in 2020 we encouraged patients and caregivers to tap into highlights through our brand-new virtual IBD Insider program, also in partnership with the AGA.
With the help of three patient advocates, including Tina Aswani Omprakash, we hosted an IBD 101 Facebook Live event (now available to view on YouTube) and created a series of slides and resources organized by topic. Omprakash and the other patient advocates, Amber Tresca and Aaron Blocker, reviewed the Congress agenda, identified themes of particular interest to their peers, and moderated the virtual education program. During the event, a trio of clinicians, Drs. David Rubin, Megan Riehl, and Frank Scott, who had spoken at the Congress that weekend, presented their research and answered questions from the patient advocates and audience members.
“We were able to bring information [from Congress] back to patients in a way that’s digestible and comprehensible for them, so they can make the best decisions for themselves,” says Omprakash, who has had more than 20 surgeries and three ostomies in her 15-year journey with Crohn’s. “Patients don’t just want technical details; they want information about what’s going to affect them the most.”
In 2020, IBD Insider brought together 505 participants during the live airing, with hundreds of additional online views. Surveys after the event showed that patients had gained insights into topics, including diet and nutrition and clinical trials, that would fuel conversations with their healthcare providers. “That’s the overall goal,” says Laura Wingate, the Foundation’s senior vice president for education, support, and advocacy, “to empower patients to be engaged in all aspects of their care.”
American Gastroenterological Association (AGA)
The American Gastroenterological Association (AGA)—a leading GI professional association—is a natural match for the Crohn’s & Colitis Foundation, the nation’s leading IBD patient organization. We continue to partner on a number of initiatives, including the Crohn’s & Colitis Congress®, the premier educational and research meeting for IBD. Together we are committed to convening the greatest minds in IBD, empowering a multidisciplinary community of healthcare practitioners and researchers, and expanding the application of best practices for patient care.
Increasing Access & Awareness
We are striving to ensure that all members of our diverse community have access to the resources they need.
Even after in-person meetings went on hiatus in 2020, the Crohn’s & Colitis Foundation maintained its pursuit of federal- and state-based step therapy, reform increased federal medical research funding, and insurance coverage protections for people with preexisting conditions. As in years past, we had help: patients, caregivers, and other supporters continued advocating for the changes that will improve patients’ lives.
Step therapy—which requires patients to try and fail one or more insurer-preferred treatment(s) before an insurance company will agree to cover the therapy desired by the patient and their provider—often delays effective care. Thanks to our volunteer-fueled efforts, step therapy reform bills have already passed in more than half of the states in the U.S. Our ultimate goal is to pass it in all 50 states and get federal legislation enacted.
“The IBD community understands that access to the right treatment at the right time is crucial to optimizing their care,” says Sarah Buchanan, the Foundation’s director of advocacy.
Pre-pandemic, one of the most powerful ways that patients and caregivers encouraged elected officials to support IBD patient–friendly legislation was to visit them and share their personal stories. To continue that effort while social distancing in 2020, the Foundation transformed its state and federal lobbying days to virtual events. Despite the pandemic, lobbying participation held steady from prior years.
The Foundation also supported the many patients and caregivers who scheduled their own virtual legislative meetings. Volunteers spoke by phone or video conference directly with their legislators and their staff, including key committee members and House and Senate leadership. Meanwhile, the Foundation launched Advocacy Stories, a web page featuring photos and stories of people from around the country who have been negatively affected by step therapy.
“We continue to reaffirm the power of volunteers to enact policy change,” says Buchanan, who noted that the Foundation hired a grassroots advocacy manager in late 2020 to build on the year’s achievements and engage even more IBD patients from across the country in these important public policy issues.
Celebrities Speak Out
“As an IBD patient, I have had days where I can barely get out of bed …”
Mike McCready, lead guitarist for Pearl Jam
“As an IBD patient, I have had days where I can barely get out of bed, let alone try to perform on
stages around the world. It hasn’t always been easy … but throughout it all, I’ve found one constant:
the Crohn’s & Colitis Foundation.”
Mike McCready, lead guitarist for Pearl Jam
Washington State resident Teresa MacDonald was a young mother of four when she was diagnosed with Crohn’s disease almost three decades ago. Since then, she and her husband, Gordon, have made a point to share their family’s experience with state and federal legislators in order to help them understand how public policies can affect quality of life for people with IBD.
For several years, the couple has traveled to Washington, D.C., to participate in the Crohn’s & Colitis Foundation’s IBD Day on the Hill, which brings together teams of patient advocates, organized by region, to meet with their legislators in Congress. Over time, the couple has formed sustained connections with the congressional staffers who help to draft legislation, and Teresa and Gordon have begun coaching fellow patients who want to get involved in advocacy.
Children with IBD have been part of their outreach group during advocacy visits. “We all have personal stories, but it’s pretty powerful when a child says, ‘I’m 10, and if you did this it would really help me and my family and all these people in the room,’” says Teresa.
Since in-person visits were not possible during the pandemic, the MacDonalds phoned their senators instead. “Even if you’re aligned differently, it’s not a left or right issue—it’s a health issue,” says Gordon.
Sharing Facts, Busting Myths
People with IBD all too often suffer for years before they begin the journey toward an accurate diagnosis and treatment. That lag time may lead to worse patient outcomes as uncontrolled inflammation can cause damage and exacerbate symptoms.
To help people with symptoms speak up and get an accurate diagnosis more quickly, in late 2020 the Crohn’s & Colitis Foundation launched its first public outreach campaign in seven years. The Spill Your Guts public service announcement (PSA) combines a series of compelling 30- and 60-second TV spots produced by FCB Health with a new patient-centered landing page. The campaign helps people make sense of the pain and digestive problems they might feel too embarrassed to discuss, detailing persistent symptoms and explaining how important it is to find a medical expert and get an accurate diagnosis.
The concept behind Spill Your Guts emerged from some startling statistics: while over 85% of the general population has heard of IBD, less than 30% describe themselves as “familiar” with the symptoms. “If people don’t even know what the symptoms are, they won’t know the right questions to ask their doctor,” says Judy Hoffstein, the Foundation’s chief marketing and communications officer.
The campaign also serves to raise awareness of IBD among the general public—including those who might be able to allow someone with IBD access to a restroom or extend support to a friend or loved one coping with the disease.
The Foundation recognizes the importance of having diverse and inclusive leaders and has been working with the Foundation’s National Board of Trustees and its National Scientific Advisory Council (NSAC) on actively recruiting new members to meet this goal.
The NSAC comprises more than 200 physicians, nurses, and advanced practice providers, psychologists, social workers, dietitians, and scientists who serve three-year terms and provide advice regarding the Foundation’s research, education, support, and advocacy efforts. To recruit more diverse members of the NSAC for the upcoming three-year term, we reached out to organizations like the National Hispanic Medical Association, the National Black Nurses Association, and historically Black medical schools.
The National Board of Trustees, which governs the entire Foundation, has also prioritized diversifying its ranks in recent years by redoubling its efforts to identify and recruit more women and people of color to serve on the Board. “If we don’t look like the people we serve in the community, we are less likely to serve them well,” says Judy Hoffstein, the Foundation’s chief marketing and communications officer.
Bridging Gaps Between Clinicians and Insurers
When a provider believes a patient would benefit from a treatment or procedure that’s not automatically covered, how can the doctor and health insurance company (payer) work together to streamline the prior authorization process? “Despite having the same goal of providing patients with optimal care, healthcare providers and insurers’ decision-makers are rarely given the opportunity to collaborate toward this outcome,” says Orna Ehrlich, vice president of strategic impact.
To change that—and ensure that patients get the best care in a timely fashion—the Foundation expanded its provider-insurer program in 2020 from small in-person discussions to larger virtual roundtables. The roundtables were held in several new regions; follow-up virtual events in select cities further increased communication and engagement between the payer and provider communities.
The Foundation also hosted several online activities for payers to increase their understanding of IBD care and learn about opportunities to collaborate with the provider community. Seventy-nine percent of those who’ve participated in our payer online programming in 2020 have said that they intend to make changes in their practice and/or that their current practice has been reinforced by their participation.
Improving Remission Rates
We're driving toward better patient quality of life, increased disease management, and inclusive research.
Harnessing Big Data
Advances in precision medicine are dependent on data—lots of it. The Crohn’s & Colitis Foundation has been a leader in this area since its creation of IBD Plexus® in 2017. IBD Plexus is now the largest U.S. data platform in the IBD field, providing researchers with access to data from over 25,000 patients and 160,000 biosamples, such as blood, stool, and intestinal tissue.
In 2020, the Foundation generated a gold mine of genetic and biosignature data from patients’ biosamples. “The Foundation is acting as a catalyst to drive fundamental acceleration in big data science and biological discovery through generation and integration of high-impact, complex data from thousands of patients,” says Caren Heller, MD, MBA, chief scientific officer at the Foundation, “which is a critical step toward precision medicine.”
These data should help researchers and clinicians gain better understanding of the patients who don’t respond well, or lose response, to medications that are currently available to IBD patients. Insights around the unmet patient need should then motivate research into how to best meet these needs to speed development of new tailored treatments and optimization of existing therapies.
This multitude of complex data, including genotyping, whole exome sequencing, proteomics, transcriptomics, microbial metagenomics, and epigenetic data, is now available to researchers through IBD Plexus.
Celebrities Speak Out
“The Foundation gave me a sense of an extended family …”
Vishal Parvani, star of Bravo’s “Family Karma”
“The Foundation gave me a sense of an extended family, people who support you, understand you, and for
me, most importantly, help you realize that you are not alone in going through this. I am thankful to
have the Foundation as a resource to educate myself, as well as my family and friends.”
Vishal Parvani, star of Bravo’s “Family Karma”
Democratizing Data to Advance Research
Patients join clinical trials for a variety of reasons, ranging from personal benefit to sincere interest in advancing new treatments for IBD patients. Whatever the motivation, finding out that a trial has been discontinued can be devastating not only to participants but to the entire IBD community.
In 2020, the Japanese pharmaceutical company Takeda made the difficult decision to stop testing a compound called Ontamalimab that hadn’t shown enough promise to continue it as an IBD treatment. “The Foundation knew we had to step up and do everything we could to honor the contributions of participants,” says Angela Dobes, MPH, vice president of the IBD Plexus program at the Crohn’s & Colitis Foundation. That’s why, she says, the Foundation worked with Takeda to make the data and biosamples that had already been collected from these patients during these clinical trials available for other research studies by incorporating them into IBD Plexus. The next step is to make the Ontamalimab data available to as many researchers as possible.
In pursuit of this goal, and of the broader goal to make all the data and biosamples housed in IBD Plexus available to researchers, the Foundation received critical funding to expand access to IBD Plexus to the academic researcher community. With support from both the Leona M. and Harry B. Helmsley Charitable Trust and Takeda Pharmaceuticals, the Foundation released an international request for proposals (RFP) in July 2020. This RFP is aimed at academic researchers who plan to use IBD patients’ biosamples and/or research-ready data sets in their research efforts. We are grateful to the Helmsley Charitable Trust and Takeda for their support in this effort to help push forward our shared vision to enable greater use of IBD Plexus resources.
“The large amount of data and biosamples available in IBD Plexus will help unlock valuable information by allowing these funded researchers to answer new high-impact questions and move faster to develop better treatments, so we can get closer to our goal of precision medicine for IBD,” stresses Dobes.
Pursuing Pain Relief
Pain in IBD is common, yet it’s not always clear why. “At least 20% to 40% of patients report chronic abdominal pain during periods of remission of their IBD,” says Gerard Honig, PhD, associate director of research innovation. In 2020, the Foundation expanded its efforts to better understand and address chronic pain in several ways. To identify knowledge gaps in pain research, we invited neuroscientists, IBD researchers, clinicians, and pain specialists to attend a virtual Pain in IBD workshop. Outcomes of this special meeting will help guide us as we solicit and vet proposals for research on chronic pain in 2021. We’re especially interested in studies that seek to explore the biological mechanisms underlying chronic pain as well as those that explore treatment alternatives to opioids.
In the meantime, we’ve already added several pain-focused videos to the IBD Clinical Hub of educational resources for clinicians. “Treating pain for IBD can be tricky, so it is really important to provide clinicians with the latest evidence on this evolving topic,” says Orna Ehrlich, vice president of strategic impact. We also launched a suite of patient-facing educational materials about pain in IBD.
“There is often a focus on the treatment of the disease, but something many patients struggle with is pain and fatigue,” says Catherine Soto, senior director of patient education and support. “Patients should know that inflammation is often a key component to addressing the underlying causes of pain. It is important for patients to have a discussion with providers about ways to appropriately manage pain and fatigue.”
Making Research More Inclusive
IBD can affect anyone, no matter their gender, age, race, or ethnicity. Yet there have only been limited small studies that address the racial disparities in IBD care. “We know that many Black patients tend to have an aggressive disease course, but we don’t know why,” says Andres Hurtado-Lorenzo, PhD, vice president of translational research. “Is it due to differences in biology? Or is it due to health disparities leading to delayed diagnoses and use of less effective treatments?”
The Foundation is trying to answer these questions through INPUT (INcidence, Prevalence, Treatment and OUTcomes in Patients with IBD), a five-year research study to build an ethnically diverse patient registry. The research, funded by a $3.25 million grant from the Centers for Disease Control and Prevention (CDC), is in its third year.
In 2020, the Foundation also partnered with pharmaceutical company Pfizer, Inc., to issue a request for proposals specifically focused on reducing health disparities among medically underserved patients with IBD. In October, Pfizer Global Medical Grants provided grants for two projects: one to the Boston University School of Medicine to create tailored screening systems to improve outcomes for underserved patients and one to the American Gastroenterological Association (AGA) Institute to use digital health services to help patients stay up-to-date on preventive care, such as screenings and vaccines.
“We see some stark socioeconomic and racial inequities among patients, especially when it comes to preventive care screenings like colonoscopies and vaccinations,” says Orna Ehrlich, the Foundation’s vice president of strategic impact. “We’re hopeful that these research projects will yield tangible solutions that we can use to reduce disparities and improve outcomes.”
Centers for Disease Control and Prevention (CDC)
The Foundation first received funding from the Centers for Disease Control and Prevention (CDC) in 2008, when they supported our study on the prevalence of IBD and variations in its treatment and outcomes throughout the state of Rhode Island. We continue partnering with the CDC on the ongoing INPUT study, which aims to determine the incidence and prevalence of IBD in the U.S., including among diverse communities, and to identify how racial disparities impact IBD treatment patterns and disease outcomes.
Advancing New Therapies & Technologies
We're leading the way in accelerating novel therapies and innovative products that address unmet patient needs.
The Future Is Personal
One of the most challenging aspects of IBD is the fact that response to the same treatment varies widely. “In some patients a given medicine can lead to remission, yet in others it may not have any effect,” explains Andres Hurtado-Lorenzo, PhD, vice president of translational research.
Enter precision medicine, which entails personalizing treatment based on a patient’s biological and clinical characteristics. Before we can develop such tailored therapy, however, we first need to identify reliable biomarkers—which are measurable indicators of disease, such as specific genes, proteins, or microbes—that can predict clinical outcomes, including a response to therapy in an individual.
There’s an urgent need for better IBD biomarkers, notes Hurtado-Lorenzo. That’s why in 2018, 2019, and 2020, the Foundation hosted the IBD Biomarkers Summits, which brought together leading stakeholders, including researchers, regulatory agencies, and patient advocates. The outcomes from the 2018 and 2019 Summits were summarized in 2020 in a special issue of the Foundation’s journal Inflammatory Bowel Diseases, with a focus on the most current advances in different biomarkers and how they can be applied both in the clinic to enhance patient care and to accelerate drug development.
A particular area of focus for the Foundation has been in prognostic biomarkers, which indicate how the disease may develop over time. In 2020, the Foundation partnered with LifeArc, a non-profit venture philanthropy organization, to develop the first-ever clinical lab test designed to predict disease course for children with Crohn’s disease. The test leverages findings from the Foundation’s Pediatric RISK Stratification Study and aims to predict, at the time of diagnosis, the likelihood of developing different types of Crohn’s disease complications.
“While around 20% of pediatric Crohn’s patients end up developing severe complications such as fistulas, up until now we’ve had no way of knowing, at the time of diagnosis, which patients would fall into that category,” explains Hurtado-Lorenzo, who notes that those likely to experience severe disease could benefit from starting anti-TNF therapy early on. “Use of this clinical lab test would be a major advance toward delivering precision medicine for children with Crohn’s, and the Foundation is excited to be leading the way.”
Of course, it’s also important to identify prognostic biomarkers in the adult IBD population. Hurtado-Lorenzo is now addressing this issue as the recently appointed chair of a working group formed by the Biomarkers Consortium of the Foundation for NIH (FNIH) to identify biomarkers of fibrosis in IBD. “This is one of the most common complications in IBD, but also one of the most difficult to manage because currently there are no available anti-fibrotic therapies and so, intestinal obstruction due to fibrosis usually requires surgery,” he says. “Identification of fibrosis biomarkers will be critical to support effective clinical trials for the development of anti-fibrotic therapies by pharmaceutical companies.”
In 2020, the Foundation entered a partnership with LifeArc, a venture philanthropy organization that advances translation of early science into healthcare treatments or diagnostics. Our joint goal: to develop the first clinical lab test to accurately predict which children with Crohn’s will be most likely to develop complications so they can be treated accordingly. The development of this prognostic test leverages findings from the Foundation’s Pediatric RISK Stratification Study, the largest study of children who are newly diagnosed with Crohn’s disease.
Celebrities Speak Out
“I support the Foundation for its unwavering optimism …”
Douglass Williams, chef and owner of MIDA in Boston
“I support the Foundation for its unwavering optimism and determination to help those living with IBD
chart a personal and community-supported path forward.”
Douglass Williams, chef and owner of MIDA in Boston
An Innovative Way to Reduce Inflammation
Most IBD drugs on the market have a serious downside: by suppressing inflammation, they compromise the body’s ability to fight off infections. Scientists at Thetis Pharmaceuticals believe there’s a better way to combat disease.
Thanks in part to support from IBD Ventures, the venture philanthropy arm of the Crohn’s & Colitis Foundation that funds novel research-based products, Thetis Pharmaceuticals is in the process of developing TP-317, a potential first-in-class oral therapy for IBD. Unlike anti-inflammatory drugs, which block the onset of inflammation by suppressing the immune system, TP-317 promotes resolution (healing and tissue repair) without compromising immune function. The active ingredient in TP-317 is Resolvin E1, a molecule that’s naturally produced by the body when it’s healing after an injury. Our understanding of Resolvin E1’s unique reparative mechanism in the intestine is supported by previous academic projects sponsored by the Foundation.
When bodily tissue is injured, two phases of inflammation occur: onset and resolution. “The resolution phase is not a passive process,” says Gary Mathias, MBA, co-founder and chief executive officer of Thetis Pharmaceuticals. “Naturally occurring molecules, including Resolvin E1, coordinate healing and the return to normal tissue. By delivering Resolvin E1 therapeutically, we can directly promote healing in the intestines and provide IBD patients with a safe and natural way to control their disease.”
Thetis Pharmaceuticals is currently using its IBD Ventures investment to learn more about how to properly dose TP-317, which uses proprietary technology to stabilize Resolvin E1. Mathias adds that toxicology studies have already been completed, thanks to previous work conducted on a different Resolvin E1 drug. “Based on feedback from the Food & Drug Administration, we would be allowed to begin clinical investigation without any additional toxicology studies,” says Mathias.
The company hopes to start clinical trials in 2022.
Getting to the Root Cause of Disease Activity
Mounting evidence suggests that microbes play a key role in activating an immune response in the gut, which sets off the development of IBD in susceptible people. Figuring out which bacteria are most problematic—and why—is a crucial area of research. Thanks to Foundation-supported initiatives, we’re getting closer to some answers that could provide relief for patients.
In 2014, the co-founders of Artizan Biosciences (who were scientists at Yale at the time) developed a technology platform called IgA-SEQ that can detect which bacterial strains in a person’s gut are heavily coated with Immunoglobulin A (IgA), an immune system antibody. “The immune system is tagging these and saying, ‘I’m suspicious of you,’” says James Rosen, MBA, MSPH, president and chief executive officer of Artizan Biosciences.
The scientists then used data from the Crohn's & Colitis Foundation–led OSCCAR study, which contains a wealth of information and samples from IBD patients. “Sure enough, there were bacterial strains in people with IBD that were heavily coated with IgA, and the same strains were less coated in people who did not have IBD,” says Rosen. This led to a major discovery: that IgA-coated bacteria can be therapeutic targets.
Artizan, with support from the Foundation’s IBD Ventures program, is now attempting to create such a therapy. They isolated bacteria from Crohn’s patients and found that it damaged the intestinal wall when transferred into mouse models by producing a toxin. The company has created an antibody designed to neutralize the toxin, and is working to make that antibody suitable for use in humans. They are also taking advantage of IBD Plexus to identify patient populations most likely to respond to this targeted therapy.
“If we’re right about the virulence factors [toxins] being causal agents, then we could actually stop someone’s IBD,” says Rosen “This could truly be game-changing for patients.”
The Crohn’s & Colitis Foundation makes it a priority to help accelerate the discovery and development of treatments for patients with IBD. In 2020, several such projects were presented at the third annual IBD Innovate conference. This yearly meeting focuses on compelling research on diagnostics and treatments while also allowing stakeholders to network with one another.
“When we bring the IBD community closer together, it increases the likelihood that researchers can find the people and support they need to bring these products to patients quickly and efficiently,” explains Paul Larkin, PhD, manager of research innovation.
This year the conference was held virtually in November and had over 300 attendees—more than twice the number of past years' events. The event featured discussion on an array of topics: Amy Lightner, MD, associate professor of surgery in the Department of Colon and Rectal Surgery at Cleveland Clinic, presented several small studies that suggest stem cells might be used to treat fistulas. Gil Melmed, MD, co-director of the Inflammatory Bowel Disease Center at Cedars-Sinai Medical Center, presented research on using UV light to treat inflammation in the colon caused by mild to moderate ulcerative colitis. Other presenters discussed delivering drugs directly to the gut and new biological approaches to decrease immune cell trafficking.
The conference also highlighted several IBD Ventures projects, including the drug being developed by Artizan and a live bacterial therapeutic product being developed by Vedanta Biosciences.
The Foundation will continue to encourage groundbreaking research in 2021 by hosting an Accelerating Enrollment of Patients into Clinical Trials Summit.
Biomarkers Consortium of the Foundation for the National Institutes of Health (FNIH)
The Biomarkers Consortium (BC) of the Foundation for NIH (FNIH) is a public-private research partnership that seeks to discover, develop, and gain regulatory approval for biological markers to support new drug development. The BC develops collaborative projects that include participants from the NIH, FDA, not-for-profit organizations, academia, and pharmaceutical and biotechnology companies. As part of their recent focus on IBD, members of the Foundation's research department, Drs. Caren Heller, Andres Hurtado-Lorenzo, and Gerard Honig have been active participants in the BC working groups that are focused on development of research projects to advance the discovery and validation of biomarkers of mucosal healing in ulcerative colitis and fibrosis in Crohn’s. They also participate in the Joint Steering Committee that selects and approves new biomarker research efforts for inflammatory diseases. The active partnership of the Foundation with the Biomarkers Consortium of FNIH is another testament to our commitment to advance biomarkers for use in IBD.
Funding the Future
We raise money to fund research as well as patient education, support, and advocacy activities.
Our Biggest Fundraisers of 2020
In a typical year, the Crohn’s & Colitis Foundation garners support from a broad range of donors, many of whom participate in such in-person events as local chapter galas, Take Steps walks, Team Challenge endurance events, and spin4 crohn’s & colitis cures. In 2020, the majority of the Foundation’s fundraising events went virtual, yet the goals remained the same: to engage constituents, build rapport and awareness in the IBD community, and help the Foundation raise money to advance research on Crohn’s and colitis.
In 2020, Take Steps successfully transitioned more than 80 local walks to two national TAKE STEPS + VIRTUAL livestream events in the spring and fall that reached an audience of almost 20,000 people and raised $7.5 million.
When in-person endurance events were canceled for the year, Team Challenge adopted “Gutsy,” a whimsical pink intestine emoji for the Get Gutsy: Tour Across America™. More than 700 participants pitched in, including 232 newcomers to the Team Challenge program, some of whom were newcomers to the Foundation itself. Together, they logged 40,000 miles through a digital app that took Gutsy on a social media tour across the continent and back again, helping Team Challenge raise a total of $1.44 million in 2020.
YouTube star Rebecca Zamolo put a new spin on the virtual incarnation of spin4 crohn’s and colitis cures, hosting a virtual house party on December 5 that brought together nearly 1,000 participants in 48 states and raised $1.25 million.
At the local level, chapters got creative, taking an additional 68 special events from in-person to virtual experiences. The Northwest chapter held its first ever Epicure event online, providing attendees with a private concert from Pearl Jam’s Mike McCready and singer Brandi Carlile, while raising an impressive $600,000. Other chapters featured the Chief Medical Correspondent for CBS News Dr. Jonathan LaPook, the Gin Blossoms, Broadway actress Kelli O’Hara, and celebrity chef Douglass Williams at their virtual events, bringing in a total of $14.4 million.
“IBD can be extremely isolating—some people can’t leave home, or might be embarrassed about symptoms or feel less supported and understood,” says Traci Osborne, the Foundation’s national marketing manager. “Virtual events allowed us to forge connections and open new opportunities for people to be part of a larger community, no matter where they live or their current state of health.”
Lauren Lapkus Wins Big for the Foundation
Right before the popular game show Who Wants to Be a Millionaire? shut down production because of COVID-19, actor, comedian, and writer Lauren Lapkus—best known for her roles in Netflix’s Orange Is the New Black and HBO’s Crashing—took the stage and won half a million dollars for the Crohn’s & Colitis Foundation!
“I could not believe it,” says Lapkus, who recently starred in the Netflix movie, The Wrong Missy. “It was truly the craziest moment of my life.” She says that as soon as the show approached her about being a celebrity competitor, she instantly knew she’d designate the Foundation as her charity of choice.
Lapkus says she’s intimately familiar with the struggles involved with living with IBD because a family member has IBD, as do some close friends. “A few of my favorite people in the world have Crohn’s disease,” she says. Lapkus says she joined one of them in volunteering at Camp Oasis when she was in her in early 20s, and the experience truly moved her. “I did it for five summers and met so many amazing people,” she says.
Lapkus volunteered at Camp Oasis of Wisconsin, where there’s both a lake and a beach. She was particularly moved by watching how the children became more confident, noting that they quickly learned that it was safe to enjoy themselves in the water and that even having an ostomy shouldn’t get in the way of their fun. “You’d see the kids transform from day one to the end of camp, which is only a week. It’s not a long time but it’s so transformative.”
As for her big game show win, Lapkus said she was “on cloud nine” knowing that she was able to help a cause she’s so passionate about. “I’ve made donations before, but nothing like this!”
Financials and Donors
More than 80 cents of every dollar the Crohn’s & Colitis Foundation spends goes to research, education, awareness, or support services.
The Foundation's net revenue saw impressive growth year over year.