A study of a drug by Teva Pharmaceutical Industries and Sanofi showed promising results in treating Crohn's disease and ulcerative colitis, meeting key goals. The drug, duvakitug, demonstrated significant clinical remission rates in patients compared to a placebo.
JERUSALEM (Reuters) -Israel's Teva Pharmaceutical Industries and French drugmaker Sanofi said a study of a drug to treat ulcerative colitis and Crohn's disease showed it had met primary goals. Teva and Sanofi said last year they would collaborate on developing a treatment for inflammatory bowel disease (IBD), hoping it will become a blockbuster drug - or one that generates annual sales of at least $1 billion. Sanofi, a leader in immunology, had said it will invest $1.
5 billion in the development of Teva's anti-TL1A drug undergoing phase 2 trials.In the 14-week phase 2b study by Sanofi and Teva's U.S. affiliate held in the U.S., Europe and Israel, the drug, called duvakitug, showed that 36.2% of low dose and 47.8% of high dose patients achieved clinical remission compared with 20.45% on a placebo. The companies said the treatment was consistent across subgroups and that this was the first and only randomized, placebo-controlled study to evaluate the impact of a TL1A antibody in Crohn's disease. “The results from the ... study have exceeded our expectations,' said Eric Hughes, head of global R&D and chief medical officer at Teva. Jefferies analyst Glen Santangelo said the trial results will alleviate investor concerns that had pressured Teva's shares post its third-quarter results.Teva and Sanofi said duvakitug was generally well-tolerated in both ulcerative colitis and Crohn's disease'with no safety signal identified'. 'These unprecedented results show that duvakitug could represent the next frontier in treating ulcerative colitis and Crohn’s disease. If the magnitude of effect persists in the Phase 3 programme, we believe we will have a differentiated medicine for IBD patients who are in urgent need of new options,' said Houman Ashrafian, Sanofi's head of R&D. The efficacy and safety of the drug have not yet been evaluated by any regulatory authority, they sai
DRUGS CROHN's DISEASE ULCERATIVE COLITIS PHARMACEUTICALS CLINICAL TRIALS
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