Teva reports positive celiac drug trial results

• Teva reported positive Phase 2a results for TEV ‘408, an anti-IL-15 monoclonal antibody for celiac disease.
• The trial met its primary endpoint by reducing gluten-induced intestinal damage compared with placebo.
• TEV ‘408 holds FDA Fast Track designation and is also being studied in vitiligo.

Teva Pharmaceutical Industries (NYSE:TEVA) reported positive topline Phase 2a results for TEV ‘408, its investigational anti-IL-15 monoclonal antibody for adults with celiac disease following a gluten-free diet.

The randomized, placebo-controlled study enrolled 50 participants who received a single subcutaneous dose of TEV ‘408 followed by a six-week daily gluten challenge, with the trial meeting its primary endpoint at week 8.

The study showed a statistically significant treatment effect on gluten-induced intestinal damage, with an LS mean change in villous height-to-crypt depth ratio of -0.43 for TEV ‘408 compared with -0.88 for placebo, representing a treatment difference of 0.45, while intestinal inflammation markers and gastrointestinal symptom scores also improved compared with placebo.

Teva stated that TEV ‘408 was well-tolerated with no emerging safety signals.

Teva Pharmaceutical Industries develops and markets prescription medicines, including generic medicines, specialty medicines, and investigational therapies across multiple therapeutic areas.

TEV ‘408 has received FDA Fast Track designation for celiac disease and is also being developed for vitiligo, supported by a funding agreement with Royalty Pharma of up to $500 million to accelerate development activities.