Tulisokibart

Teva and Sanofi announced positive mid-stage results ahead of schedule for their inflammatory bowel disease candidate as they look to keep pace in an anti-TL1A race with Merck and Roche. The duo’s duvakitug met the primary endpoints in a Phase 2b trial evaluating patients with ulcerative colitis and Crohn’s disease, two forms of IBD, Teva and Sanofi said Tuesday morning. In ulcerative colitis, 36.2% of patients taking a low dose of duvakitug and 47.8% of patients taking a high dose achieved clinical remission, compared to 20.45% of placebo patients at week 14. P-values came in at 0.05 and 0.003 for the low and high doses, respectively. In Crohn’s disease, 26.1% of low-dose duvakitug patients and 47.8% of high-dose patients saw an endoscopic response as measured by a scoring system for Crohn’s severity, compared to 13% on placebo (p-values were 0.058 for the low dose and <0.001 for the high dose). While 0.05 is typically considered the gold standard for assessing statistical significance, a Teva spokesperson said the Phase 2 study had a “one-sided test at a significance of 0.1.” The partners said duvakitug was “generally well-tolerated,” with similar rates of treatment-emergent adverse events occurring in the treatment and placebo arms. Sanofi put down €469 million ($500 million) upfront in a deal to co-develop and co-commercialize duvakitug with Teva in October 2023. The anti-TL1A contest also includes Roche, which put down $7.1 billion upfront in late 2023 to acquire Roivant’s subsidiary Telavant and RVT-3101. Merck is also a rival, following its acquisition of Prometheus Biosciences and its MK-7240 in a deal worth $10.8 billion. The duvakitug topline results came earlier than expected, due to “significant acceleration in patient recruitment,” Sanofi and Teva said back in July. As a result, they skipped an interim analysis which was originally planned for the second half of this year. Now, the partners said they plan to initiate a Phase 3 trial in 2025 in IBD “pending regulatory discussions.” A Teva spokesperson declined to share further specifics on the timing of Phase 3 initiation or the dose that will be taken forward. Each company will share the development costs globally, while Sanofi will lead Phase 3 development. Teva will lead commercialization in Europe, Israel and certain other countries, and Sanofi will take the commercial lead in North America, Japan and other parts of Asia, and the rest of the world. Editor’s Note: A correction has been made to reflect that Teva and Sanofi are studying duvakitug in inflammatory bowel disease, not irritable bowel disease.

A Teva Pharmaceuticals drug being developed in partnership with Sanofi to hit a promising but competitive target for inflammation now has positive data from a clinical test in the two most common types of inflammatory bowel disease (IBD), results the companies say support the antibody’s best-in-class potential. The preliminary results announced Tuesday are from a placebo-controlled Phase 2b test that enrolled 240 patients with either ulcerative colitis or Crohn’s disease. The experimental drug, duvakitug, was administered as a subcutaneous injection every two weeks for 14 weeks. In ulcerative colitis, 36.2% of those treated with the low dose and 47.8 of those treated with the high dose achieved clinical remission compared to 20.45% of those given a placebo. In Crohn’s disease, endoscopic response was achieved by 26.1% of those in the low-dose group and 47.8% in the high-dose group. Just 13% of those in the placebo arm met that mark. Teva said these responses to duvakitug were both statistically significant and clinically meaningful. presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions On measures of safety, the companies said duvakitug was well tolerated in both the ulcerative colitis and Crohn’s cohorts. They added that rates of adverse events were similar between the study drug arms and the placebo groups. The companies plan to present more Phase 2b details at an upcoming scientific meeting in 2025. But with these encouraging preliminary results in hand, the companies are now preparing for a longer and larger IBD Phase 3 study, which will be led by Sanofi. Duvakitug goes after a target called tumor necrosis factor (TNF)-like ligand 1A, or TL1A. Signaling of this protein is believed to drive inflammation and fibrosis associated with IBD. TL1A binds to two receptors, one that maintains homeostasis and the other which promotes pro-inflammatory signaling, Teva said in an investor presentation. By selectively binding to DR3, the pro-inflammatory receptor, duvakitug is intended to mitigate the signaling that drives IBD. The drug was initially discovered and developed by Teva, which is better known as a maker of generic and biosimilar medicines. But the company has also been devoting resources to the R&D of novel drugs that offer the potential for stronger revenue growth. Last year, Sanofi signed on as a partner in the development of duvakitug, formerly known as TEV-48574. The pharma giant paid €469 million (about $500 million) up front, and committed to up to €940 million (about $1 billion) in milestone payments. It’s one of several deals in what has become a hot area of inflammatory drug research. Merck’s TL1A-targeting drug, tulisokibart, came via an acquisition, as did Roche’s contender, RO7790121. Both are in mid-stage clinical development. Further behind but still in the hunt is AbbVie, which struck a deal earlier this year that brought a preclinical drug candidate that targets TL1A. In a note sent to investors, Leerink Partners analyst David Risinger characterized the duvakitug results as “surprisingly compelling.” In both ulcerative colitis and Crohn’s, the drug’s data appear stronger than its competitors. Cross-trial comparisons come with caveats due to differences in study designs, but Risinger said duvakitug is showing greater placebo-adjusted efficacy versus its competitors in the TL1A class. However, he also noted that duvakitug’s study tested dosing every two weeks while rival drug candidates were tested with dosing every four weeks. Consumer / Employer Health Executives on Digital Transformation in Healthcare Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare. By MedCity News Teva and Sanofi are gathering data for the longer dosing interval. Participants who completed the 14-week Phase 2b test could continue receiving treatment in a long-term extension study lasting 44 weeks. Dosing in this study is every four weeks. Following the positive preliminary Phase 2b results, the next steps include discussions with regulators about Phase 3. “These unprecedented results show that duvakitug could represent the next frontier in treating ulcerative colitis and Crohn’s disease,” Houman Ashrafian, executive vice president, head of R&D at Sanofi, said in a prepared statement. “If the magnitude of effect persists in the Phase 3 program, we believe we will have a differentiated medicine for IBD patients who are in urgent need of new options.”