Teva's immune disorder drug meets main goal in mid-stage trial
Teva's immune disorder drug meets main goal in mid-stage trial Sept 2 (Reuters) - 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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Teva's immune disorder drug meets main goal in mid-stage trial (updated)