TEV ‘408, an anti‑IL‑15 monoclonal antibody discovered by Teva, showed a statistically significant reduction in gluten‑induced intestinal damage in a Phase 2a trial involving adults with celiac disease. The primary endpoint was met at week 8.
Trial Shows Reduced Intestinal Damage
The randomized, placebo‑controlled investigation enrolled 50 participants who were already on a gluten‑free diet and had minimal baseline villous atrophy (Vh:Cd ≤ 2.0). Two weeks after a single subcutaneous dose, subjects began a six‑week daily gluten challenge.
At the end of the challenge period, the Vh:Cd ratio changed by –0.43 in the active arm versus –0.88 for placebo, yielding a treatment difference of 0.45 (95 % CI 0.06‑0.84, p < 0.05). The data align with the hypothesis that blocking IL‑15 can protect the intestinal lining.
Secondary biopsy measures also favored the antibody. Intraepithelial lymphocyte density rose by 27.60 cells mm⁻² in the control group but only 0.37 cells mm⁻² in treated participants, a difference of –27.23 (95 % CI –39.67 to –14.79).
Patient‑reported outcomes improved as well. Scores on the Celiac Disease Symptom Diary dropped more sharply in the active cohort, indicating fewer gastrointestinal complaints during the challenge.
Safety Profile Remains Favorable
The compound was well‑tolerated; no safety signals emerged through the eight‑week assessment. Adverse events were comparable between groups and none were deemed related to the investigational product.
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These findings come as the company prepares additional analyses and plans to present further data at a future scientific meeting.
For people living with the condition, current management relies on strict dietary avoidance, yet inadvertent exposure remains common. A therapy that targets the underlying immune driver could lessen daily vigilance and improve quality of life.
The next phase will explore longer‑term dosing and broader patient populations. An investor call and live webcast are scheduled for today at 8:00 a.m. ET, with a recorded version to follow.
IL‑15 is a cytokine that amplifies immune‑mediated injury in the small intestine. By neutralizing this signal, the antibody aims to curb the cascade that leads to villous flattening and nutrient malabsorption.
The antibody is also being investigated in a vitiligo program, reflecting its potential across multiple immune‑mediated diseases.
Details of the call, including registration information, are available on the company’s investor‑relations portal.
