ABIVAX (NasdaqGM:ABVX) Conference Transcript

Summary of ABIVAX Conference Call - October 06, 2025 Company Overview - Company: ABIVAX (NasdaqGM:ABVX) - Event: Conference call discussing late-breaking abstracts presented at the UEG conference in Berlin Key Points Industry and Product Focus - Product: Oripazimod, a first-in-class molecule for treating ulcerative colitis (UC) [5][6] - Target Population: Patients with severe refractory ulcerative colitis, including those who have failed multiple therapies, including JAK inhibitors [9][10] Clinical Data Highlights - Phase III Trials: Two induction trials leading to a maintenance trial, with a focus on the most refractory patient population [7][8] - Patient Severity: Approximately 60% of patients had the highest endoscopic severity score (3) [10] - Treatment History: About 50% of patients had previously failed at least one advanced therapy, with a notable number being JAK refractory [10][11] - Efficacy Metrics: - Delta of 16% in clinical response for the 50 mg dose compared to placebo, and 13% for the 25 mg dose [11] - Significant endoscopic improvement observed, particularly in patients with high baseline severity [14][15] Safety and Tolerability - Adverse Events: Headaches were the most common side effect, with no significant difference in serious treatment-emergent adverse events between the treatment and placebo groups [20][21] - Lipase Levels: Elevations in lipase were noted but were below typical thresholds for clinical concern, with no associated abdominal pain or pancreatitis [78][79] Future Expectations and Positioning - Maintenance Data: Anticipated to be released next year, with expectations that it may show improved outcomes over Phase II data [77][78] - Positioning in Treatment Spectrum: The drug is expected to be positioned as a first-line treatment for naive patients and as an option for those with multiple therapy failures [36][40] - Market Awareness: Increased recognition and enthusiasm for oripazimod among clinicians, with a focus on its oral administration and potential to improve patient quality of life [90][91] Additional Insights - Dosing Flexibility: Emphasis on the ability to adjust dosing based on patient response and severity, with a preference for higher doses in refractory cases [66][67] - Long-term Efficacy: Historical data suggests that patients may continue to improve over time, indicating the need for longer observation periods in refractory populations [46][48] Conclusion - Overall Sentiment: Positive outlook on oripazimod's potential to become a leading treatment option for ulcerative colitis, with ongoing data collection and analysis to support its efficacy and safety profile [98][99]