Duvakitug

New data are informing Sanofi and Teva’s phase 3 plans. \n Sanofi has shared a deeper dive into its 469 million euro ($491 million) bowel disease bet, publishing phase 2 data that provide a clearer look at how the Teva-partnered prospect compares to Merck & Co. and Roche’s rival candidates.The French drugmaker paid Teva for rights to co-develop and co-commercialize the anti-TL1A therapy in 2023. Late last year, the partners shared top-line data from a phase 2 trial in ulcerative colitis and Crohn’s disease. The December readout showed duvakitug improved outcomes in the two most common forms of inflammatory bowel disease but left key questions about the molecule’s prospects unanswered.Monday, Sanofi and Teva filled in some of the gaps at the 20th Congress of the European Crohn’s and Colitis Organisation. The updated readout shows duvakitug’s effect on key secondary endpoints and in subgroups of advanced therapy naïve and experienced patients.After 14 weeks, the rates of endoscopic improvement were 45% and 50%, respectively, on the low and high doses of duvakitug. Sanofi and Teva reported endoscopic improvement in 23% of placebo patients. The secondary endpoint sheds light on how duvakitug compares to the competition on a key outcome in ulcerative colitis. Sanofi and Teva’s 27% placebo-adjusted rate of endoscopic improvement falls in the middle of the rivals’ range. Roivant, the source of Roche’s TL1A prospect, reported a 21% delta compared to placebo after 12 weeks. Prometheus Biosciences, which Merck acquired, saw a 31% placebo-adjusted rate of endoscopic improvement at Week 12 of its phase 2 ulcerative colitis trial.The new duvakitug data also clear up the question of whether the hit on the primary endpoint of clinical remission was driven by subgroup performance. Sanofi and Teva saw higher rates of clinical remission on duvakitug than placebo regardless of whether patients had previously tried an advanced therapy. The partners reported the highest placebo-adjusted rates in advanced therapy experienced participants.Similarly, endoscopic response rates in the Crohn’s cohort were higher on duvakitug than placebo in naïve and experienced patients. The pattern is less clear in the Crohn’s data. The partners reported the highest and lowest placebo-adjusted rates in advanced therapy experienced participants, with the low dose and high dose figures coming in at 7% and 44%, respectively.The data are informing Sanofi and Teva’s phase 3 plans. Last month, Teva Chief Medical Officer Eric Hughes, M.D., Ph.D., told investors the partners had just “put the final touches” to the phase 3 design. The design is “really based on the modeling and simulation that we\'ll use from this first study,” the Teva executive said. In a note discussing the results this morning, analysts at Leerink Parners said the latest data reinforce duvakitug\'s “exceptional profile.” The analysts expect Sanofi to bring in 1 billion euros ($1.05 billion) in sales of the drug in 2032.