As Merck and Roche continue to march their respective inflammatory bowel disease (IBD) assets through the clinic, Sanofi and Teva are closing the gap with positive data on their own anti-TL1A antibody duvakitug.
In the phase 2b RELIEVE UCCD trial, duvakitug met the mark in patients with ulcerative colitis (UC) and Crohn’s disease (CD)—the most common forms of IBD—Sanofi and Teva said Tuesday.
When looking at UC specifically, 36.2% of patients on a low dose of duvakitug and 47.8% of patients on a high dose achieved clinical remission compared to 20.45% of those on placebo.
As for the study’s CD cohort, 26.1% of participants on a low dose and 47.8% of participants on a high dose achieved an endoscopic response versus 13% of patients in the trial’s control arm.
The findings mean duvakitug met the study’s primary endpoints, Sanofi and Teva said in the release. Additionally, the antibody proved “consistent across subgroups” and appeared well tolerated in both IBD conditions with no safety signals identified, according to the partners. Overall rates of treatment-emergent adverse events were similar between treatment and placebo groups across both indications.
The trial outcome could represent the “next frontier” in UC and CD treatment, Sanofi’s head of research and development, Houman Ashrafian, M.D., Ph.D., said in a statement. Meanwhile, Teva’s global R&D chief and chief medical officer, Eric Hughes, M.D., Ph.D., said the results “exceeded our expectations.”
With the new findings in hand, Sanofi and Teva are now plotting a phase 3 study for duvakitug, pending talks with regulators.
Duvakitug hails from Teva’s labs, though Sanofi got in on the action last October when it laid out $500 million upfront to partner on development and marketing of the antibody.
Under the deal, which could see Teva net up to $1 billion in development and launch milestones, Sanofi is on deck to lead late-stage development of duvakitug. Should the drug score approval, Sanofi will handle marketing duties in North America, Japan and other parts of Asia while Teva takes charge of commercial activities in Europe, Israel and “specified other countries.”
The readout not only exceeded Teva's expectations but also came earlier than expected.
Back in July, the partners revealed that the phase 2b trial had completed enrollment early thanks to “significant acceleration in patient recruitment.” In light of the speedy recruitment drive, the partners said they were scrapping a planned interim analysis in the back half of the year and shifting the trial’s expected readout 2024’s fourth quarter.
Now, Sanofi and Teva intend to present detailed results from the duvakutig study at a medical meeting in 2025.
While other pharma majors like Roche and Merck are trying their hands at the TL1A approach in UC, Sanofi and Teva say their trial was the first placebo-controlled study to examine the effects of the drug class in CD.
Merck is working on the monoclonal antibody MK-7240—formerly known as PRA023—which it acquired in its $10.8 billion buyout of Prometheus Biosciences last year.
In phase 2 results disclosed in late 2022, MK-7240 helped 26.5% of UC patients enter clinical remission by the study’s 12-week mark, versus a slim 1.5% of their peers on placebo.
At the time, Prometheus also shared evidence from a single-arm study suggesting the antibody improves outcomes in CD, too. The investigational drug is now being studied in phase 3 trials for both UC and CD.
Roche took a similar approach to its TL1A ambitions, locking down access to the IBD antibody RVT-3101 through its $7 billion acquisition of Roivant subsidiary Telavant last fall. At the time of the buyout, RVT-3101 had already passed a phase 2b study in patients with moderate to severe UC.