Teva’s TEV-408 Hits Key Phase IIa Endpoint in Celiac Disease Study
The antibody showed statistically significant prevention of gluten-induced intestinal damage and was well tolerated, Teva said.
- On Wednesday, Teva Pharmaceutical Industries announced positive topline results from a Phase 2a study of TEV-408, an investigational antibody for celiac disease. The drug met its primary endpoint by preventing gluten-induced intestinal damage.
- Celiac disease affects about 1% of the global population, or more than 3 million people in the United States, yet currently lacks approved therapies. Patients rely on a strict gluten-free diet despite risks of inadvertent gluten exposure.
- In the study of 50 participants, TEV-408 demonstrated statistically significant prevention of gluten-induced intestinal damage versus placebo after eight weeks. The drug was well-tolerated, with no safety signals identified to date, according to Teva.
- Following encouraging Phase 1b data, Teva is advancing the asset into a Phase 2b study for vitiligo. Royalty Pharma agreed in January to provide up to $500 million to accelerate the drug's development.
- Dr. Eric Hughes, Teva's Chief Medical Officer, said the results indicate potential to address celiac disease at its biological source. The company plans further analysis and will present additional results at a future scientific meeting.
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Israeli company on verge of breakthrough in celiac drug development
Teva has reported significant progress in its pipeline of innovative drugs, with TEV '408, the company's experimental drug for treating celiac disease, meeting its primary endpoint in a Phase 2a clinical trial. Teva considers the drug an asset with significant commercial potential, having previously estimated that peak sales of the celiac treatment could reach approximately […] The post Israeli company on verge of breakthrough in celiac drug dev…
Teva’s TEV-408 Hits Key Phase IIa Endpoint in Celiac Disease Study
Teva Pharmaceutical Industries (NYSE:TEVA) reported positive topline results from a Phase IIa gluten-challenge study of TEV-408, its anti-IL-15 antibody candidate for celiac disease, with the company saying the treatment met its primary endpoint and showed statistically significant effects on key me
The Toronto Star
Teva Announces Positive Topline Results from Phase 2a Study in Celiac Disease for Its Anti-IL-15 Antibody, Further Validating Its Pipeline-in-a-Product Potential
Teva-discovered TEV ‘408, a novel anti-IL-15 monoclonal antibody, demonstrated statistically significant and clinically meaningful prevention of gluten-induced intestinal damage vs placebo following a single subcutaneous dose.TEV ‘408 was well-tolerated with no safety signals observed to date.Together with the vitiligo program,…
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