Paris-based biotech Abivax has reached a milestone in its attempt to address the unmet needs of patients living with moderate to severe ulcerative colitis. The company recently announced positive top-line data from its global phase III ABTECT program, in which the lead candidate, obefazimod (ABX464), demonstrated remarkable efficacy data and favorable tolerability results in managing the inflammatory condition. With these top-line results from the induction phase and 44-week maintenance data anticipated by Q2 2026, Abivax is now working toward a potential New Drug Application submission in the second half of 2026. CEO Marc de Garidel tells us more.
How did Abivax manage to exceed enrollment targets and achieve one of the fastest-enrolling ulcerative colitis trials of its kind?
This achievement stemmed from a dedicated company-wide effort to raise awareness among investigators and referral sites. One of the key tactics, which we believe had a significant impact, included visits to the clinical trial sites by a diverse team of Abivax representatives, including Medical Science Liaisons and the executive leadership team.
Furthermore, Abivax benefited from a robust collaboration with IQVIA. This partnership provided crucial operational support and infrastructure. Once investigators gained a thorough understanding of the therapy's unique mechanism of action, and were convinced by the outcomes demonstrated in the phase IIb trial, their willingness to actively identify and enroll patients accelerated considerably. The fact that nearly 100 sites with prior positive experience from the phase IIb trial also actively participated in the phase III ABTECT trials provided a significant head start and established momentum for rapid enrollment.
What factors contributed to maintaining consistency in patient baseline characteristics between the phase IIb and phase III trials?
Our objective for this study was to enroll a patient population comparable to that of our phase IIb trial, with the goal of replicating the previously observed efficacy outcomes. To achieve this, we established inclusion and exclusion criteria that closely mirrored those used in the phase IIb study, namely patients with moderate-to-severe ulcerative colitis who previously had an inadequate response, loss of response, or intolerance to conventional or advanced therapies. Throughout the recruitment process, the team remained highly disciplined in applying these criteria to ensure consistency and scientific rigor across both studies.
You have recently announced phase III trial results. Can you summarize these?
At the end of July, we reported that obefazimod, our first-in-class miR-124 enhancer, demonstrated highly significant and clinically meaningful efficacy, with a pooled 16.4 percent placebo-adjusted remission rate at eight weeks. In the individual ABTECT-1 and ABTECT-2 studies, placebo-adjusted remission rates were 19.3 percent (p<0.0001) and 13.4 percent (p=0.0001), respectively, at a once-daily oral dose of 50 mg. There also was a significant clinical response, with a reduction in disease scores, in 63.3 percent of treated patients. The strength of these results reinforces our belief in obefazimod and its potential to become a transformative new treatment modality for patients with UC. Pending successful results from the 44-week maintenance trial, we are preparing to submit a New Drug Application to the FDA in the second half of 2026.
What steps are being taken to prepare for the NDA submission?
We have assembled sub-teams within our departments to begin the work on the NDA submission, even before the induction or maintenance data readouts, so we are as advanced as possible as we await the phase III maintenance data. On top of the data and our regulatory approval plans, we have raised a significant follow-on round totalling $747.5 million to enable us to achieve an NDA submission and still have a healthy cash runway.
What are the challenges associated with conducting large-scale trials across such diverse geographies?
Trials across diverse geographies present many challenges, regardless of the size of the company sponsor. These included varied regulations in different countries, cultural and language barriers, logistical challenges in the supply chain, participant recruitment and data management. Abivax employs industry experts who have been involved in successful, large ulcerative colitis trials in the past, and we have leaned on their expertise in managing these challenges. Our partnership with IQVIA, one of the leading CROs in the IBD space, has been a real help.
Can you speak to the commercial potential of obefazimod in the US and European markets if approved?
Favorable characteristics have been demonstrated in the phase IIb and phase III induction trials, namely ease of administration, a strong safety profile, and durable efficacy. Assuming these are further confirmed, we intend to position obefazimod as a preferred treatment option for patients who have failed a first-line advanced therapy. At launch, we anticipate that payers will likely require patients to fail a biosimilar before reimbursing obefazimod. Over the course of the next couple of months we will be conducting market research to assess the commercial potential of obefazimod incorporating the induction data into the target product profile (TPP), as the data we presented last week was far better than the assumptions that we used for our prior TPP.
How does Abivax plan to differentiate obefazimod from existing treatments?
We believe obefazimod offers a compelling differentiation from existing treatments for moderately to severely active ulcerative colitis. Unlike many current therapies, which are administered via injection and associated with serious risks such as malignancies and opportunistic infections, obefazimod is an oral, once-daily therapy, providing a more convenient and patient-friendly alternative that may also improve long-term adherence.
Even among currently available oral therapies, obefazimod stands apart. Existing options often require extensive pre-treatment screening, ongoing monitoring, and carry black box warnings for serious adverse events, including thrombosis, infections, and liver toxicity. In the phase IIb trials, obefazimod demonstrated a differentiated safety and tolerability profile with no evidence of increased risk of serious infections, malignancy, or thrombotic events.
Also in the phase IIb trial, obefazimod showed durable clinical remission and endoscopic improvement, with efficacy sustained through 48 weeks of treatment in over 60 percent of responders. These results highlight obefazimod’s potential to offer long-term disease control without the safety trade-offs often seen with existing therapies. Pending confirmation of these outcomes in phase III, we believe obefazimod is well-positioned to become the treatment of choice for patients with inadequate response or intolerance to first-line advanced therapies.
Beyond ulcerative colitis, are there plans to expand obefazimod's application to other chronic inflammatory diseases?
Yes, reduced expression of miR-124 has been implicated in the pathogenesis of several chronic inflammatory diseases, including Crohn’s disease. In October of 2024 we commenced another phase IIb clinical trial in Crohn’s disease and we are actively exploring additional indications where the modulation of miR-124 could provide meaningful clinical benefit.
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