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

Sept. 2 (Reuters) - Israeli drugmaker Teva Pharmaceutical Industries 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 agreed in January to provide Teva with up to $500 million to accelerate the drug's development.