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Teva's immune disorder drug meets main goal in mid-stage trial

Teva's immune disorder drug meets main goal in mid-stage trial

- Israeli drugmaker Teva Pharmaceutical Industries TEVA.TA, TEVA.N said on Wednesday its experimental drug helped prevent gluten-related intestinal damage in adults with celiac disease, meeting the main goal of a mid-stage trial.

U.S.-listed shares of the company were up over 4% in premarket trading.

  • Celiac disease is an autoimmune condition in which gluten triggers an immune response that damages the small intestine. It affects about 1% of the global population, including more than 3 million people in the United States, according to Teva.

  • The antibody treatment, known as TEV-408, blocks IL-15, a protein involved in the immune reaction to gluten.

  • In the study, 50 patients following a gluten-free diet were randomly assigned to receive a subcutaneous injection of TEV-408 or a placebo. Two weeks after receiving a single dose, participants were instructed to consume gluten daily for six weeks.

  • A single injection significantly reduced damage and inflammation in the small intestine compared with a placebo after eight weeks. Patients also reported fewer digestive symptoms, Teva said, adding that no new safety concerns were identified.

  • There are no approved treatments for the condition. Patients rely on a strict gluten-free diet, though accidental exposure can still cause symptoms and intestinal damage.

  • Teva plans further analysis and will present additional results at a future scientific meeting. TEV-408 is also being tested for vitiligo and is set to enter another mid-stage trial for the skin condition.

  • Royalty Pharma RPRX.O agreed in January to provide Teva with up to $500 million to accelerate the drug's development.


(Reporting by Kunal Das in Bengaluru; Editing by Nivedita Bhattacharjee)

((Kunal.Das2@thomsonreuters.com;))

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