Teva Reports Significant Prevention Of Gluten-Induced Damage in New Study

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) on Wednesday reported encouraging topline outcomes from an active Phase 2a clinical trial evaluating TEV ‘408, an experimental anti-interleukin-15 monoclonal antibody, for celiac disease.

Coeliac disease is a chronic autoimmune condition where eating gluten damages the lining of the small intestine.

The trial successfully achieved its primary goal, revealing that the investigational treatment significantly prevented intestinal damage caused by gluten consumption when compared to a placebo at the eight-week mark.

Study Design And Clinical Methodology

Researchers enrolled 50 adult patients diagnosed with celiac disease who maintained a strict gluten-free diet and displayed minimal intestinal damage at the study’s onset.

Two weeks following a single administration of the TEV ‘408 antibody, the participants initiated a rigorous six-week daily gluten challenge.

The clinical trial team evaluated patient-reported symptoms alongside comprehensive biopsy measurements to track intestinal inflammation and structural damage.

Key Efficacy And Inflammation Metrics

At the conclusion of the eight-week gluten challenge, TEV ‘408 demonstrated a clinically meaningful defense against gluten-induced damage.

The treatment yielded a least squares mean change in the trial’s primary endpoint, the villous height-to-crypt depth ratio, of -0.43. This significantly outperformed the placebo group’s -0.88 change.

Furthermore, the investigational antibody positively impacted intestinal inflammation.

Participants receiving TEV ‘408 experienced a minimal increase of 0.37 in intraepithelial lymphocyte density. In contrast, the placebo group saw a substantial surge of 27.60 in the same inflammatory marker.

Symptom Relief And Ongoing Research

Patients treated with TEV ‘408 also recorded lower gastrointestinal symptom scores on the Celiac Disease Symptom Diary when compared to those taking the placebo.

Medical professionals noted that participants tolerated the treatment well, with no emerging safety concerns or signals identified throughout the process.

Teva is currently conducting additional analyses of the ongoing Phase 2a study.

TEVA Price Action: Teva Pharmaceutical Indus shares were up 3.04% at $37.29 at the time of publication on Wednesday. The stock is approaching its 52-week high of $38.36, according to Benzinga Pro data.

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