New Moves in Science: Addressing the Unmet Needs of Inflammatory Bowel Disease Patients
At Teva we are currently investigating a treatment for inflammatory bowel disease.
Approximately 4.9 million people01 worldwide live with inflammatory bowel disease (IBD), a chronic inflammatory disease affecting the digestive system. IBD is the collective term referring primarily to two conditions, ulcerative colitis (UC) and Crohn’s disease (CD).
How many people are affected by IBD?
Incidences of IBD are on the rise and an increasing number of people have been diagnosed02 over the last 20 years. Its prevalence is increasing in western countries03, with a high burden of IBD in North America, Australia, New Zealand and Europe, as well as in newly industrialized nations in Africa, Asia and South America.
IBD has a debilitating impact04 across many areas of patients' lives and its range of symptoms include weight loss, diarrhea, abdominal pain, rectal bleeding, and fatigue.05
Patients with UC and CD may also experience long-term complications of the disease. These include the development of intestinal fibrosis, leading to intestinal strictures. Fibrosis is common in patients with CD06 but less well established in UC07 which can further impact the patients' quality of life.
What are the treatment options?
There is currently no cure for IBD08. The overarching goal of treatment09 is to induce remission, which is associated with improved quality of life, while preventing long-term complications. But while several treatment options are available for UC and CD, they may not all work for every patient10 or may stop working over time.11
In a partnership with Sanofi announced in Q4 202312, Teva is developing a new therapy that targets the fibrotic component of IBD to address unmet needs for the treatment of UC and CD.
How does the investigational therapy work?
Dr Dalbir Dhiraj is the global medical director for the program, leading its medical strategy and working closely with colleagues in clinical development, regions and operations to ensure everything is running on track. Or, as she describes it, “my team and I act like the glue between several different functions in Teva and the external world, bringing them together”.
She describes how the therapy is thought to work.
A cytokine has been identified that contributes to inflammation by amplifying existing inflammatory signals. Inflammation can be protective in the human body, but too much inflammation can lead to cellular damage, tissue damage and scarring. This cytokine also drives fibrosis13 and is implicated in numerous immune-mediated and fibrotic diseases, making it an ideal target for therapeutic intervention14.
Teva has developed a human antibody that targets this cytokine with a dual mechanism of action demonstrating anti-fibrotic and anti-inflammatory effects, as shown in preclinical studies.15
Initial results
Initial results from trials show target engagement with a rapid and sustained decrease in free cytokine levels, with no significant safety signals observed to date. These results were presented at the 19th Annual Congress of the European Crohn’s an Colitis Organization (ECCO) in February 2024.
Why is this important?
Providing a treatment that targets the fibrotic component of IBD would be a first in the industry and a major innovation for patients.
“The formation of fibrotic lesions in patients’ digestive systems is detrimental,” says Dalbir. “It can cause the formation of fistulas and strictures, ultimately resulting in sections of the colon that are full of scar tissue and will often require surgery.”
Collaborating for strength
Teva’s partnership with global immunology leader Sanofi leverages both companies’ R&D strengths and commercial expertise in inflammatory diseases.
“We really do believe that the partnership between the two companies will accelerate the development of this asset,” says Eric Hughes, MD, PhD, Chief Medical Officer and Head of Global R&D at Teva. “With Sanofi’s global leadership in immunology and ability to advance large-scale clinical programs, we are confident in our ability to potentially address a significant unmet medical need."
“This collaboration with Teva underscores our strategy of exploring novel mechanisms of action that look differently at both disease drivers and downstream effects of chronic inflammatory conditions,” says Dietmar Berger, Chief Medical Officer and Head of Development at Sanofi. “The dual inflammatory and fibrotic components of IBD require a more innovative strategy to fully address the clinical impact of this disease.”
Because at the end of the day, it’s all about the patients.
“Every individual involved in this program has the patient at heart, whether it's designing the clinical study, delivering educational materials or anything else,” says Dalbir. “And that's really important because that's why we're doing this. That's why we're working so hard on this program because we want to have a positive impact on patients' lives and the lives of their caregivers and families, helping to support people who are living day in day out with these conditions.”
NPS-ALL-NP-01294-JULY-2024
Find out more:
How can we use AI to make medicines more efficiently?
What are the 3 biggest elements shaping clinical development today?
Want to get involved in the inspiring work we do? Check out our Careers pages
-
Back to contents.
BMJ. Global, regional and national burden of inflammatory bowel disease in 204 countries and territories from 1990 to 2019, 2023. Available at https://bmjopen.bmj.com/content/bmjopen/13/3/e065186.full.pdf. Accessed July 2024
-
Back to contents.
CDC. Prevalence of IBD, 2022. Available at https://www.cdc.gov/inflammatory-bowel-disease/about/index.html. Accessed July 2024
-
Back to contents.
NIH. Epidemiology of Inflammatory Bowel Diseases, 2023. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9860659/. Accessed July 2024
-
Back to contents.
The American Journal of Gastroenterology. ACG Clinical Guideline: Management of Irritable Bowel Syndrome, 2021. Available at https://journals.lww.com/ajg/fulltext/2021/01000/ACG_Clinical_Guideline__Management_of_Irritable.11.aspx?context=LatestArticles. Accessed July 2024
-
Back to contents.
CDC. What is inflammatory bowel disease (IBD)?,2022. Available at https://www.cdc.gov/inflammatory-bowel-disease/about/?CDC_AAref_Val=https://www.cdc.gov/ibd/what-is-IBD.htm. Accessed July 2024
-
Back to contents.
NIH. Novel biomarkers of fibrosis in Crohn’s disease, 2016. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4981766/. Accessed July 2024
-
Back to contents.
Journal of Digestive Diseases. Epidemiology of fibrostenosing inflammatory bowel disease, 2020. Available at https://onlinelibrary.wiley.com/doi/full/10.1111/1751-2980.12853. Accessed July 2024
-
Back to contents.
MDPI. Inflammatory Bowel Disease Treatments and Predictive Biomarkers of Therapeutic Response, 2022. Available at https://www.mdpi.com/1422-0067/23/13/6966. Accessed July 2024
-
Back to contents.
Springer Link. Treatment of inflammatory bowel disease, 2011. Available at https://link.springer.com/article/10.1016/S1734-1140(11)70575-8. Accessed July 2024
-
Back to contents.
MDPI. Inflammatory Bowel Disease Treatments and Predictive Biomarkers of Therapeutic Response, 2022. Available at https://www.mdpi.com/1422-0067/23/13/6966. Accessed July 2024
-
Back to contents.
EMJ. Current Therapy in Inflammatory Bowel Disease: Why and How We Need to Change?, 2022. Available at https://www.emjreviews.com/innovations/article/current-therapy-in-inflammatory-bowel-disease-why-and-how-we-need-to-change-j080121/?site_version=EMJ. Accessed July 2024
-
Back to contents.
Tevapharm. Sanofi and Teva Announce Exclusive Collaboration to Deliver Inflammatory Bowel Disease Treatment, 2023. Available at https://www.tevapharm.com/news-and-media/latest-news/sanofi-and-teva-announce-exclusive-collaboration-to-deliver-inflammatory-bowel-disease-treatment/. Accessed July 2024
-
Back to contents.
NIH. Direct signaling of TL1A-DR3 on fibroblasts induces intestinal fibrosis in vivo, 2020. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7584589/. Accessed July 2024
-
Back to contents.
NIH. An anti-TL1A antibody for the treatment of asthma and inflammatory bowel disease, 2018. Available at https://pubmed.ncbi.nlm.nih.gov/29436901/. Accessed July 2024
-
Back to contents.
Taylor & Francis. An anti-TL1A antibody for the treatment of asthma and inflammatory bowel disease, 2018. Available at https://doi.org/10.1080/19420862.2018.1440164. Accessed July 2024
