As Sanofi attempts to bounce back from a tough year of clinical readouts, the French pharma has touted longer-term phase 2 data for its bowel disease bet as showing the Teva-partnered prospect remains a “key opportunity in our pipeline.”
Sanofi and Teva had already shown in late 2024 that the anti-TL1A antibody, called duvakitug, improved outcomes in ulcerative colitis (UC) and Crohn’s disease—the two most common forms of inflammatory bowel disease—in the phase 2 Relieve UCCD study. Both arms of the study hit their primary endpoint of clinical remission, they reported at the time.
At 14 weeks, 36.2% of UC patients on the lower dose of duvakitug and 47.8% of those on the high dose achieved the primary goal of clinical remission, compared to 20% of those on placebo. When it came to the Crohn’s cohort, which had a primary endpoint of endoscopic response, the rates were 26.1% and 47.8%, respectively, versus 13% for placebo, according to the December 2024 readout.
Now, Sanofi and Teva have provided 44-week data they claim show “durable clinical and endoscopic efficacy.”
The extension stage of the study enrolled 130 patients who had responded to duvakitug in the initial part of the trial. These patients were re-randomized to receive a 450-mg or 900-mg subcutaneous dose of duvakitug every four weeks.
Among the patients with UC, 47% of those on the 450-mg dose and 58% of those on the 900-mg dose achieved clinical remission at 44 weeks. For Crohn’s patients, for whom the primary endpoint was again endoscopic improvement, the rates were 41% and 55%, respectively.
Both doses of duvakitug were well tolerated, according to Sanofi, with the most frequent observed adverse events being upper respiratory tract infection, nasopharyngitis, Crohn’s and hypertension.
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For Sanofi, which announced its decision last week to oust its CEO following a year of clinical setbacks, this morning’s data are a reminder that the company’s pipeline still holds promise.
“These results reinforce duvakitug’s potential as a leading TL1A therapy and an important advancement in inflammatory bowel disease treatment with durable efficacy maintained for nearly one year in patients living with ulcerative colitis or Crohn’s disease,” Sanofi’s head of R&D Houman Ashrafian, Ph.D., said in a Feb. 17 release.
“With phase 3 studies underway, we’re committed to advancing duvakitug for patients who need new options, and it remains a key opportunity in our pipeline,” Ashrafian added.
The French drugmaker paid Teva $500 million for rights to codevelop and co-commercialize the anti-TL1A therapy in 2023. Analysts have previously alluded to duvakitug’s “exceptional profile” and suggested the drug could bring in 1 billion euros ($1.2 billion) in sales in 2032.
Still, duvakitug is set to go up against rival anti-TL1A antibodies like Merck & Co.’s tulisokibart and Roche’s afimkibart, which are both also in phase 3 development.
“One of the persistent challenges in treating ulcerative colitis and Crohn’s disease isn’t just achieving an initial response, but sustaining it,” Teva Chief Medical Officer Eric Hughes, M.D., Ph.D., said in this morning’s release.
“These phase 2b results further reinforce TL1A as a compelling target and clearly strengthen the case that duvakitug has the potential to be a best-in-class therapy,” Hughes added. “They also provide further evidence to support additional indications we anticipate announcing this year, with the goal of bringing meaningful innovation to patients.”
