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Jump to Key Points 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 nearly 3% in early trading.
• Celiac disease is an autoimmune condition in which gluten triggers an immune response that damages the small intestine. It affects more than 3 million people in the United States, according to Teva.
• In the study, 50 patients following a gluten-free diet were randomly assigned to receive a subcutaneous injection of the antibody treatment TEV-408 or a placebo. Two weeks after receiving a single dose, participants were instructed to consume gluten daily for six weeks.
- TEV-408 met phase 2 primary endpoint in celiac disease.
- Single SC dose ↓ gluten-induced small-intestinal damage vs placebo.
- 50 adults on gluten-free diet; challenged with daily gluten x6 weeks.
- Fewer digestive symptoms; no new safety concerns identified.
- No approved celiac therapy; strict gluten-free diet remains standard.
• A single injection of TEV-408 significantly reduced damage and inflammation in the small intestine compared with a placebo after eight weeks, Teva said.
• Patients also reported fewer digestive symptoms, while no new safety concerns were identified, the company added.
• There currently are no approved treatments for the condition and patients rely on a strict gluten-free diet, though accidental exposure can still cause symptoms and intestinal damage.
• Teva estimates TEV-408 could generate peak annual sales of about $1.5 billion to $2 billion in celiac disease.
• TEV-408 is also set to enter a mid-stage trial for vitiligo after early data showed improvements in skin pigmentation in patients.
• The celiac results following positive data for vitiligo positions the drug as an "exciting contributor to Teva's innovative medicines pipeline in at least two areas with large unmet need," Scotiabank analyst Louise Chen said.
• It has further potential in other diseases such as atopic dermatitis and alopecia areata, Chen added.
(Reporting by Kunal Das in Bengaluru; Editing by Nivedita Bhattacharjee and Jonathan Ananda)
