Abivax has recovered from a dent in its share price after unveiling fresh safety data that appeared to go some way toward alleviating investors’ concerns with its ulcerative colitis prospect.
At the start of June, the Paris-based biotech linked obefazimod, its oral miR-124 enhancer, to a 40%, placebo-adjusted jump in clinical remission rates in a phase 3 trial. But the share price of the biotech, a reported takeover target for several Big Pharmas, collapsed after several patients on the high dose developed cancers.
At the time, the company reported one case each of prostate cancer, breast cancer and colonic dysplasia on the high dose, compared to zero cases on the low dose or placebo. Abivax also reported two cases each of basal and squamous cell carcinoma on the high dose. There was one case of basal cell carcinoma on placebo and one case of squamous cell carcinoma on the low dose.
Now, Abivax has bookended the month with more data that it argued “provide important context for interpreting the safety findings” it unveiled June 1. The latest data come from a supplemental portion of the phase 3 study, which enrolled patients who either didn’t see a clinical response in the initial part of the trial or saw their disease return.
Among these patients, two individuals in the 25-mg arm and two in the 50-mg arm experienced non-melanoma skin cancer. All four cases “occurred in patients with established NMSC risk factors including advanced age, thiopurine use, prior skin cancer history and failure of multiple prior advanced therapies,” Abivax noted.
While two other types of cancer were also reported in the 50-mg arm, both cases were considered by the study’s investigators to be unrelated to obefazimod, the biotech said.
The company explained that its estimate of cancer incidence rates becomes more precise as cumulative exposure time increases, with the updated exposure-adjusted incidence rate across the 25-mg and 50-mg arms now “within the UC background reference range based on published UC studies.”
“The expanded cumulative safety data further strengthens our confidence in the long-term safety profile of obefazimod and reinforces the favorable benefit-risk profile for our program as we prepare for our planned NDA submission later this year,” Abivax CEO Marc de Garidel said in the June 29 release.
“We believe this growing body of evidence positions obefazimod, if approved, to become a paradigm-defining treatment option for patients living with ulcerative colitis,” de Garidel added.
The company paired the safety data with more efficacy findings, including results showing that moving patients up to a 50-mg dosing regimen recaptured clinical remission in 45.5% of patients who relapsed in the initial part of the trial. Abivax said the finding “support[s] a practical dose-escalation strategy for regaining and sustaining disease control over time.”
Investors appeared to be appeased, sending the company’s stock up 38% to $132.89 when markets opened Tuesday and helping the biotech recover the ground it lost earlier this month.
Abivax emerged as a top M&A target last year, with AstraZeneca and Eli Lilly reportedly among the companies interested in a deal that could be worth $18 billion, after reporting eight-week data from a phase 3 trial of obefazimod. The data suggested the small molecule, which upregulates miR-124 in immune cells, could disrupt the huge, highly competitive inflammatory bowel disease market.
With Abivax, which has indicated an interest in partnering obefazimod outside the U.S., waiting for the 48-week data before pursuing a deal, the maintenance readouts this month emerged as key moments for the biotech and its suitors.
Abivax said Monday that it remains on track to submit an NDA to the FDA for obefazimod in ulcerative colitis in the fourth quarter. The biotech expects to publish phase 2b induction data in Crohn’s disease in mid-2027.