Breakthrough Clinical Results
Abivax announced late-breaking presentation of 8-Week ABTECT Induction Trial results in participants with and without prior inadequate response to advanced therapies. The 50 mg dose of once-daily obefazimod achieved clinically meaningful improvements across all endpoints, regardless of prior inadequate response to advanced therapies (AT-IR). The study population included 1272 patients enrolled across the ABTECT trials, with approximately 60% being classified as having an endoscopic subscore of 3. Obefazimod treatment was well tolerated with no new safety signals identified for both the 25mg and 50mg doses.
Key Highlights
- 50 mg obefazimod achieved clinically meaningful improvements across all endpoints in ulcerative colitis patients.
- Improvements observed regardless of prior inadequate response to advanced therapies.
- Clinically meaningful improvements in clinical remission and response in participants with and without prior AT-IR.
- Obefazimod treatment was well tolerated with no new safety signals identified.
Incidence and Prevalence
Latest Global Estimates of Ulcerative Colitis Incidence and Prevalence
Prevalence Estimates
Recent epidemiological data shows significant global variation in ulcerative colitis (UC) prevalence. A 2025 systematic review and meta-analysis of 13 population-based studies involving 161,157 UC patients found a pooled prevalence of 1.54% (95% CI 1.14-1.99; I² = 96.1%). This comprehensive analysis primarily included studies from Europe, North America, and Asia, with limited representation from South America, Africa, and Oceania.
In regional contexts, a 2024 Saudi Arabian study reported that among 875 inflammatory bowel disease (IBD) patients, 345 (39.4%) had ulcerative colitis. Additionally, a Danish study focusing on microscopic colitis reported a prevalence of 197.9 cases per 100,000 inhabitants as of December 2016, noting that microscopic colitis incidence had surpassed that of both Crohn's disease and ulcerative colitis.
Incidence Trends
The incidence of UC shows notable geographic and demographic variations. A 2024 systematic review and meta-analysis reported a rising incidence of pediatric UC in numerous countries since 1970, though with significant geographical differences. Meta-regression analysis revealed that geographic location and socioeconomic factors significantly influenced UC incidence rates.
In Germany, a 2022 study reported increasing incidence of IBD in children and adolescents, with UC accounting for 33.1% (n = 176) of pediatric IBD cases. The Danish study mentioned earlier reported that the overall mean incidence of microscopic colitis was 20.7 per 100,000 person-years.
Mortality and Disease Burden
A 2022 global mortality study reported an age-standardized mortality rate (ASMR) of 0.76 [0.73-0.79] deaths per million inhabitants for UC. Worldwide trend analysis showed a statistically significant decrease in ASMR from 2001 to 2015 (mean annual percent change: -1.29%, p<0.001), though with significant geographical disparities.
Changing Global Distribution
Traditionally viewed as a disease of Western countries, UC prevalence is now increasing in developing regions. A 2018 review noted that epidemiologic studies from African and Middle Eastern countries suggest disease trends similar to Western patterns, representing an important health and economic burden. A 2020 systematic review confirmed that inflammatory bowel diseases, including UC, are rapidly growing in developing countries.
Treatment Patterns
A 2024 global meta-analysis reported that UC patients had a 9.70% (95% CI 6.20-13.18%) prevalence of biologic use, which was lower than in Crohn's disease patients (21.41%).
Cancer Risk
The 2025 meta-analysis also reported a pooled colorectal cancer incidence in UC patients of 1.47 per 1000 person-years (95% CI 1.30-1.67; I² = 66.2%). The standardised incidence ratio (SIR) for colorectal cancer in UC patients was 2.48 (95% CI 1.64-3.76; I² = 91.7%).
Key Unmet Needs and Target Populations for Ulcerative Colitis
Unmet Needs in Treatment
Maintenance of long-term remission remains a significant unmet need in ulcerative colitis (UC) treatment. Current conventional treatments fail to "achieve the ultimate goal of the therapy," highlighting a critical gap in disease management. The therapeutic gap of 30%-60% with infliximab and adalimumab further emphasizes the need for newer agents.
Head-to-head comparisons between targeted therapies are notably lacking, creating an unmet need for direct comparative evidence to determine optimal treatment approaches. This gap complicates clinical decision-making when selecting the most appropriate therapy for individual patients.
Safety concerns with conventional treatments represent another significant challenge, as these therapies are "associated with various limitations and side-effects," including drug resistance and adverse reactions. This has prompted exploration of natural remedies as alternatives with "comparatively less side effects" and better affordability.
Target Populations
Moderate-to-severe UC patients constitute a key target population requiring novel therapies. Recent clinical trials (2023-2025) have evaluated promising agents including: - Etrolizumab for induction and maintenance of clinical remission - Upadacitinib 45mg, which demonstrated superior efficacy in achieving clinical remission - Etrasimod 2mg/kg, which ranked first in clinical remission during maintenance phase
Mild to moderate UC patients represent another important target group, with research focusing on achieving histological remission as a robust target for long-term outcomes.
Immune checkpoint inhibitor (ICI)-induced colitis patients form an emerging population requiring specialized treatment approaches, as "ICIs cause adverse events such as diarrhea and enterocolitis, thus warranting treatment discontinuation."
Patients in developing countries face unique challenges in UC management, including limited access to healthcare, inadequate early diagnosis, insufficient patient education, and poor medication adherence. Recent epidemiologic studies from African and Middle Eastern countries suggest disease trends similar to Western regions, with increasing prevalence in these developing areas.
Emerging Approaches
Personalized therapy tailoring treatment to individual disease characteristics and risk factors is anticipated to become critical for more effective care. New treatment strategies include early intervention, dose optimization, positioning newer agents as first-line therapies, and combination approaches.
Microbiome-based interventions show promise, with research exploring specific compounds, probiotics, and fecal microbiota transplantation for inflammation reduction and symptom alleviation.
The management of acute severe ulcerative colitis and prevention of urgent colectomy (which carries higher mortality than elective procedures) represent additional areas of focus, highlighting the need for better medical management to avoid emergency surgeries.
Other Drugs Being Trialled with the Same MoA as Obefazimod
There is insufficient information available to identify other drugs being trialled for the same indication using the same mechanism of action (MoA) as obefazimod. Without details about obefazimod's specific mechanism of action or the indication it is being developed to treat, it is not possible to identify comparable drugs in clinical trials.
Similarly, without information about related drugs sharing obefazimod's mechanism of action, no details can be provided regarding the intervention models being employed in their clinical trials.
The mechanism of action of a drug refers to the specific biochemical interaction through which a drug produces its pharmacological effect. Different drugs targeting the same biological pathway for the same medical condition would be considered to share a mechanism of action.
Intervention models in clinical trials typically include: - Parallel assignment (participants assigned to one of multiple groups) - Crossover assignment (participants receive different treatments in sequence) - Factorial assignment (testing multiple interventions simultaneously) - Single group assignment (all participants receive the same intervention) - Sequential assignment (treatment assigned based on previous outcomes)
For a comprehensive understanding of drugs sharing obefazimod's mechanism of action and their trial designs, additional information about obefazimod's specific properties and therapeutic target would be required.