Obefazimod Shows Long-Term Benefits in Ulcerative Colitis

Obefazimod 50 mg once daily demonstrated efficacy in patients with moderate to severely active ulcerative colitis (UC), with 52.5% achieved clinical remission at 96 weeks of open-label maintenance treatment with improvement in endoscopy scores and faecal calprotectin levels.
METHODOLOGY:
Obefazimod is an investigational oral small molecule that enhances the expression of a single micro-RNA regulating the inflammatory response. In a phase 2b, randomised placebo-controlled 8-week induction trial, obefazimod at three different doses achieved the primary endpoint in patients with moderate to severely active UC.
This 96-week open-label maintenance study was conducted including 217 patients (mean age, 42.1 years; 61.3% men) with moderate to severely active UC who were recruited at 69 study centres in 14 countries. All participants received 50 mg obefazimod once daily, regardless of their previous treatment and irrespective of their clinical response at the end of the induc­tion trial.
After week 48, patients who showed clinical response, defined as a decrease in the modified Mayo score ≥ 2 points and ≥ 30% from baseline plus a decrease in the rectal bleeding subscore ≥ 1 or absolute rectal bleeding subscore ≤ 1, continued the treatment up to week 96.
Efficacy endpoints included rates of clinical remission, clinical response, endoscopic improvement, and endoscopic remission, along with the change in the stool frequency and faecal calprotectin levels from baseline of the maintenance study, assessed using non-responder imputation for missing data.
Safety measures comprised the incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), discontinuations due to TEAEs, drug-related SAEs, and clinically significant laboratory abnormalities.
TAKEAWAY:
Of the 217 patients, 164 completed the study at week 96. By weeks 48 and 96, 81.6% and 72.8% of patients achieved a clinical response and 54.8% and 52.5% achieved clinical remission, respectively; endoscopic improvement was seen in 59.0% of patients and endoscopic remission seen in 35.9% at week 96.
Faecal calprotectin levels decreased from a median of 204.7 µg/g at baseline in the maintenance study to 89.6 µg/g at week 96, and 61.9% of patients achieved levels below 150 µg/g at week 96.
At both weeks 48 and 96, the proportion of patients who achieved the efficacy endpoints was numerically higher among those who showed a clinical response at week 8 than among those who did not. A proportion of patients also achieved corticosteroid-free endoscopic improvement and remission.
Overall, 68.2% of patients experienced at least one TEAE, with the most common being COVID-19 infection (14.3%) and headache (11.5%). TESAEs occurred in 8.3% of patients, and 7.8% discontinued because of TEAEs. No new safety signals or clinically meaningful changes in laboratory parameters were noted.
IN PRACTICE:
"[The study] findings suggest that long-term treatment with obefazimod provides continued improvement of clinical symptoms of the disease," the authors of the study wrote. "Although the central evaluation of endoscopy data reduced the risk of bias in this open-label study, the results must be interpreted with caution due to the absence of a control group," they added.
SOURCE:
This study was led by Severine Vermeire, University Hospitals Leuven, Leuven, Belgium. It was published online on May 26, 2025, in the Journal of Crohn's and Colitis .
LIMITATIONS:
Steroid cycling was not considered in the non-responder imputation method, which may have limited the interpretation of corticosteroid-free outcomes.
DISCLOSURES:
This study was supported by Abivax S.A. Seven authors reported being employees of Abivax. One author reported owning stocks in Abivax. Several authors reported receiving consultancy and/or speaking fees and grants and being consultants and advisory board members for various pharmaceutical companies.

Try Our AI Features

Explore what Daily8 AI can do for you:

Learn with AIFact CheckingText to SpeechAI Summary

Related Articles

Yahoo

3 hours ago

• Yahoo

Risk of Sleep Breathing Disorder Set to Rise 45% by End of Century

Rising temperatures could increase the chances of experiencing obstructive sleep apnea (OSA) by nearly 50 percent by the end of the century, placing a greater burden on society through loss of health, wellbeing, and productivity. This is the result of a recent investigation into the effects of local temperature increases on OSA, a condition where a person's airways become blocked while sleeping for more than 10 seconds at least five times an hour throughout the night. "This study helps us to understand how environmental factors like climate might affect health by investigating whether ambient temperatures influence the severity of OSA," says sleep scientist Bastien Lechat from Flinders University in Australia, who led the study. "Overall, we were surprised by the magnitude of the association between ambient temperature and OSA severity." Many of the nearly 1 billion people globally with this sleep disorder don't even know they have it, yet it can take a serious toll on their health. Aside from affecting sleep quality, OSA alters the levels of oxygen and carbon dioxide in the blood. In the long term, this imbalance can affect insulin and glucose metabolism, mental function and mood, and can even lead to cardiovascular problems like heart failure and stroke. Previous research has also linked untreated or severe OSA with increased risk of dementia, Parkinson's disease, traffic accidents, and all-cause mortality. Lechat and his colleagues drew on data from an under-mattress sleep sensor used by 116,620 people across 29 countries between January 2020 and September 2023. The sensor detects movement and sound which can be analyzed to create estimates of sleep timing, quality, and breathing. The researchers matched this data – around 500 separate nights per person – with detailed, 24 hour temperature data for participant's nearest cities. In 2023, this coincided with the highest mean temperature recordings on record in over 2000 years, 2.07 °C above pre-industrial levels. "Higher temperatures were associated with a 45 percent increased likelihood of a sleeper experiencing OSA on a given night," Lechat says. "The increase in OSA prevalence in 2023 due to global warming was associated with a loss of approximately 800,000 healthy life years across the 29 countries studied. This number is similar to other medical conditions, such as bipolar disorder, Parkinson's disease or chronic kidney diseases." They estimate that the resulting wellbeing burden and workplace productivity loss cost economies a total of around $98 billion USD, with an estimated 105 million days of workplace productivity lost. All up, this would double the condition's estimated burden on society compared with today. "Importantly, these findings varied by region, with people in European countries seeing higher rates of OSA when temperatures rise than those in Australia and the United States, perhaps due to different rates of air conditioning usage," Lechat adds. Because the sleep sensors from which the data were collected are more readily available to people in higher socioeconomic countries and individuals, this study may actually underestimate the true health and economic cost of OSA exacerbated by climate change. These people may have access to better sleep environments and air conditioning, the researchers point out, mitigating the effect of temperature on their sleep. Modeling based on government climate change policies from 2020 suggests global warming will raise temperatures by around 2.1–3.4 °C by 2100, unless greenhouse gas emissions are further reduced. "The health and economic impact of these estimates would be consequential, and the increase in OSA prevalence due to rising temperatures in such scenario may double the overall OSA burden," the authors report. The research was published in Nature Communications. Breakthrough: FDA Approves Injection to Prevent HIV Is It Gastro or Food Poisoning? Here's A Guide to Your Upset Stomach Axolotl Discovery Brings Us Closer Than Ever to Regrowing Human Limbs

Health Line

3 days ago

• Health Line

Can Ulcerative Colitis Be Deadly?

Key takeaways While ulcerative colitis itself is not fatal, it's a chronic disease that needs to be properly managed to prevent serious health complications. Potentially serious health complications that can result from UC include toxic megacolon, a perforation in your bowel, primary sclerosing cholangitis, colorectal cancer, and heart disease. UC is a chronic condition that, for most people, requires lifelong treatment, and the only way to cure the condition is by having surgery to remove your colon and rectum. Ulcerative colitis (UC) is a lifelong condition that you need to manage. It's not deadly on its own, but it is a serious disease that can cause some dangerous and potentially life threatening complications, especially if you don't get the right treatment. UC is one form of inflammatory bowel disease (IBD). It causes inflammation in the inner lining of your rectum and your large intestine (also known as your colon). The other type of IBD, Crohn's disease, can affect any part of your digestive tract. When you have UC, your immune system mistakenly attacks your intestines, and these attacks lead to inflammation and sores, or ulcers, in your intestines. Treatments are available for UC. Most people with UC have a full life expectancy. However, according to one 2003 Danish study, complications can increase the risk of an early death. Ulcerative colitis complications While UC itself usually isn't fatal, some of its complications can be. Potentially serious health complications that can result from UC include: toxic megacolon a perforation (hole) in your bowel primary sclerosing cholangitis colorectal cancer heart disease Toxic megacolon The most serious possible complication related to UC is toxic megacolon, which is swelling of your colon that can cause it to rupture. This condition affects up to 10% of people with UC. Some studies show that the death rate among people hospitalized with toxic megacolon is around 6.5%. However, the death rate drops to less than 2% in people with IBD who receive an early diagnosis and prompt medical care. Bowel perforation A hole in your bowel is also dangerous. Bacteria from your intestine can get into your abdomen and cause a potentially life threatening infection called peritonitis. Primary sclerosing cholangitis Primary sclerosing cholangitis is another rare but serious complication of UC. It causes swelling and damage around your liver and in your bile ducts, which carry digestive fluid from your liver to your intestines. Scars can form and narrow your bile ducts, and this can eventually cause severe liver damage. In time, you can develop serious infections and liver failure. These conditions can be life threatening. Colorectal cancer According to a 2001 research review, people with UC have up to an 8% chance of developing colorectal cancer within 20 years of their UC diagnosis. In comparison, the review noted that the risk among the larger population was 3% to 6%. More recently, a 2023 review article noted that rates of colorectal cancer among people with UC are decreasing but are still higher than the rates in the larger population. Colorectal cancer can be fatal if it spreads to other parts of your body. Heart conditions According to a 2022 study, UC is associated with a greater risk of heart conditions, including coronary artery disease, heart failure, and atrial fibrillation. And a 2023 study suggests that people with IBD are at a higher risk of death from these types of heart conditions.

Associated Press

3 days ago

• Associated Press

Hong Kong Baptist University Showcases World-Leading Research in Digital Health & Systems Medicine at THE Global Sustainable Development Congress 2025

ISTANBUL, TURKEY - Media OutReach Newswire - 19 June 2025 – Hong Kong Baptist University (HKBU) illuminated the path to global well-being as the Global Health Innovation Partner and sponsor of the Health and Wellbeing Track at the Times Higher Education (THE) Global Sustainable Development Congress (GSDC) 2025, from June 16-19, 2025. At this gathering of over 5,000 global thought leaders, HKBU presented its comprehensive, interdisciplinary strategy for health and well-being, spearheaded by its Health & Drug Discovery research cluster. HKBU's 'Well-being Zone' showcases interdisciplinary global health, with sessions like Tai Chi, Baduanjin, and Mindfulness Karate reflecting its 'exercise is medicine' approach to holistic well-being. Firmly aligned with the United Nations' Sustainable Development Goals, HKBU's vision for health transformation drives from data to actionable insight. It comprehensively integrates mental and digital well-being, real-time analytics, and innovative interdisciplinary approaches. This includes blending traditional Chinese Medicine with cutting-edge sciences like chemical biology and data analytics, complemented by advancements in environmental, physical, and social sciences. A Hub for Holistic Health A highlight of HKBU's presence was the 6,000-square-foot 'Well-being Zone', thoughtfully designed to embody the principle that health is holistic and interconnected. This innovative Zone brought the concept of interdisciplinarity to a global audience by seamlessly integrating diverse fields, from martial arts and mindfulness to cutting-edge digital health monitoring: HKBU scholars presented cutting-edge research on global health and Chinese Medicine at GSDC 2025. Highlighting HKBU's research strength in the transformative power of technology for global health, Professor Martin Wong, Provost & Chair Professor of Computer Science, emphasised, 'HKBU's recent top-50 global ranking in databases, design automation, and artificial intelligence underscores our collaborative ethos. By integrating advanced AI methodologies with clinical, pharmaceutical and social-science expertise, we are optimising diagnostics, accelerating drug discovery and enhancing surgical assistance. This interdisciplinary approach reinforces Hong Kong's reputation as a global hub for cutting-edge research and higher education.' Professor Lyu Aiping, Vice-President (Research & Development), highlighted HKBU's strategic edge, 'Hong Kong is uniquely positioned to lead East–West integration in digital health and systems medicine. HKBU combines the rigour of life sciences with robust Chinese Medicine research, underpinned by advanced data analytics. This powerful synergy enables us to tackle complex health disparities at biological, social, and environmental levels, and build resilient, equitable health systems to meet future global challenges.' In addition to numerous insightful presentations and the interactive experiences, HKBU Provost Professor Martin Wong gave a keynote at the session entitled 'Reframing Sustainability through the Lens of Chinese Heritage and Innovation' convened by the China Education Association for International Exchange. HKBU also released the 'Evolving Legacy: Decoding the Scientific Trajectory of Chinese Medicine' Report ( in collaboration with Elsevier. This report examines the development and evolving research landscape of Chinese Medicine and its growing influence on modern healthcare. Hashtag: #HKBU The issuer is solely responsible for the content of this announcement.