Abivax reported phase 3 maintenance data showing that its experimental oral ulcerative colitis treatment, obefazimod, achieved clinical remission rates above those seen with placebo, while also reporting several cancer cases among patients receiving the higher dose.
The 44-week maintenance study evaluated once-daily 25 mg and 50 mg doses of obefazimod in patients with ulcerative colitis. Clinical remission was achieved by 50.8% of patients receiving the 25 mg dose and 51.3% of patients receiving the 50 mg dose, compared with 10.4% of patients in the placebo group.
The results corresponded to placebo-adjusted clinical remission rates of 39.3% for the 25 mg dose and 40.3% for the 50 mg dose. Although lower than the 48% placebo-adjusted remission rate that Abivax reported at Week 48 in its phase 2 open-label extension study, the findings were among the strongest reported in a large ulcerative colitis program.
Obefazimod is a small molecule designed to upregulate miR-124 in immune cells. The study population included many patients who had previously received other treatments. Approximately 40% of participants had used advanced therapies before entering the trial.
Discussing comparisons with other ulcerative colitis studies, David Rubin, M.D., a gastroenterologist at the University of Chicago, questioned how many patients in those programs had been refractory to multiple prior drugs.
Abivax also reported safety findings from the study. According to the company, infection rates were similar to those observed with placebo. Treatment-emergent adverse events leading to discontinuation occurred numerically more often in the placebo group than in either obefazimod treatment arms.
However, cancer-related findings were reported in the high-dose group. Patients receiving 50 mg of obefazimod experienced one case each of prostate cancer, breast cancer, and colonic dysplasia. The same group also recorded two cases of basal cell carcinoma and two cases of squamous cell carcinoma.
In comparison, the placebo arm had one case of basal cell carcinoma, while the 25 mg treatment group had one case of squamous cell carcinoma. Abivax stated in its study report that investigators considered the prostate cancer, breast cancer, and colonic dysplasia cases unrelated to treatment.
Commenting on the findings, Chris Rabbat, Ph.D., global head of medical affairs at Abivax, said the observed cases “are well within the range of what could be expected” for the patient population.
Rubin also addressed the cancer reports, stating that the cases are “not worrisome,” and adding that “there’s no signal.”
The company plans to submit obefazimod for U.S. FDA approval toward the end of the year. Abivax also expects to publish phase 2b induction data for obefazimod in Crohn’s disease in mid-2027. Rubin said he “fully” expects the drug’s mechanism to work in Crohn’s disease.
The phase 3 results were released as Abivax continues to attract attention because of obefazimod. Reports last year indicated that AstraZeneca and Eli Lilly were among companies interested in a potential transaction involving the drug, and Abivax has said it is interested in partnering obefazimod outside the United States.
Following the data release, investors focused on the reported cancer cases despite the efficacy results. Abivax shares fell about 28% in U.S. premarket trading and around 30% in early Paris trading.
Obefazimod has achieved a significant milestone in the treatment of ulcerative colitis after positive results from a Phase 3 clinical trial demonstrated clinical remission in patients. The encouraging findings position Obefazimod as a promising therapeutic candidate for individuals living with this chronic inflammatory bowel disease.
Ulcerative colitis affects millions of people worldwide and can significantly impact quality of life. The latest data suggest that Obefazimod may offer a new option for patients seeking effective long-term disease management.
Phase 3 Trial Results
The Phase 3 study evaluated the safety and efficacy of Obefazimod in patients with moderate to severe ulcerative colitis. Researchers reported that Obefazimod successfully met key clinical endpoints, including the achievement of clinical remission in a significant portion of trial participants.
These results strengthen confidence in the therapeutic potential of Obefazimod and support its continued development as an innovative treatment for inflammatory bowel disease.
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