Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA

• Fast Track designation granted for investigational TEV-53408, an anti-IL-15 antibody
• Designation underscores the potential of TEV-53408, currently undergoing a Phase 2a study for the treatment of celiac disease
• Candidate demonstrates Teva’s commitment to bringing important new treatment options to underserved patient populations
  

TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries, Ltd. (NYSE and TASE: TEVA) today announced that the US Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL-15 antibody, for the treatment of people with celiac disease on a gluten-free diet. TEV-53408 is currently being evaluated in a Phase 2a trial to assess the efficacy and safety in adults with celiac disease.

Fast Track is an FDA process designed to facilitate development and expedite review of drugs to treat serious conditions and address unmet medical needs.

“The FDA’s decision to grant Fast Track designation for TEV-53408, an investigational anti-IL-15 antibody therapy, reflects the promising nature of the treatment and the urgent unmet need of people living with celiac disease,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “Teva is driven by a commitment to innovation and this latest achievement gets us one step closer to providing promising, innovative treatment options for patients with chronic autoimmune diseases like celiac disease.”

TEV-53408 is an antibody designed to inhibit the activity of the cytokine, interleukin-15 (IL-15), to prevent intestinal damage and associated symptoms in individuals with celiac disease. This potential treatment is a testament to the growing strength of Teva’s innovative pipeline and dedication to advancing treatments for immunological conditions, including celiac disease, which affects approximately 1% of the global population.^1-3

About TEV-53408

TEV-53408 is an investigational monoclonal antibody that inhibits interleukin-15 (IL-15), which aims to reduce the immune response to gluten that causes intestinal inflammation and damage in individuals with celiac disease. A Phase 2a study investigating the efficacy and safety of anti-IL-15 in adults with celiac disease is ongoing (NCT06807463).

About Celiac Disease

Celiac disease is a chronic autoimmune disorder triggered by gluten, affecting the small intestine and leading to a range of symptoms. It can significantly impact an individual's quality of life, and diagnosis can be challenging. A strict, lifelong gluten-free diet is the only current treatment and even if adhering to a gluten-free diet, a significant proportion of patients still experience debilitating symptoms. In addition, trace amounts of gluten - especially through accidental or inadvertent ingestion - can cause severe reactions. Teva is dedicated to developing innovative medicines for immunological diseases, including celiac disease, with the goal of providing better health for people suffering from celiac disease worldwide.