Teva's celiac disease drug prevents intestinal damage in gluten challenge trial

Teva Pharmaceutical Industries announced positive Phase 2a results for its experimental antibody TEV-53408, which successfully prevented gluten-induced intestinal damage and reduced gastrointestinal symptoms in celiac disease patients. The drug targets the IL-15 pathway to address the disease's biological source. Backed by a $500 million Royalty Pharma funding pact, Teva is advancing the drug to a multiple-dose Phase 2 trial, eyeing a market of 5.1 million patients with no FDA-approved therapies.

TEV-53408 Phase 2a results

• ▪Teva Pharmaceutical Industries plans to proceed to a multiple-dose Phase 2 study of TEV-53408 to define the dose and regimen for a Phase 3 trial in celiac disease
• ▪In addition to preventing intestinal damage, preliminary Phase 2a results for TEV-53408 showed lower gastrointestinal symptom scores compared to a placebo, and the drug was safe and well tolerated
• ▪Teva Pharmaceutical Industries' experimental antibody drug TEV-53408 demonstrated a statistically significant and clinically meaningful ability to prevent gluten-induced intestinal damage compared to a placebo in a Phase 2a trial
• ▪The Phase 2a study of TEV-53408 enrolled 50 adults with celiac disease on a gluten-free diet who underwent a six-week daily gluten challenge starting two weeks after receiving a single dose of the drug

IL-15 pathway targeting mechanism

• ▪TEV-53408 is a subcutaneously administered monoclonal antibody designed to block interleukin-15, a signaling protein involved in the inflammation and intestinal damage associated with celiac disease
• ▪TEV-53408 has a long half-life that could potentially extend its dosing interval to once every three months

Celiac disease market potential

• ▪An estimated 5.1 million people in the United States and the five largest European Union countries have celiac disease, which currently has no FDA-approved therapies
• ▪Teva Pharmaceutical Industries is exploring TEV-53408 for other immunological indications, including vitiligo, eosinophilic esophagitis, alopecia areata, and atopic dermatitis
• ▪Teva Pharmaceutical Industries projects that TEV-53408 could reach $1.5 billion to $2 billion in peak sales for the treatment of celiac disease alone

Competitive celiac therapeutics landscape

• ▪First Track Biotherapeutics is developing ANB033, a CD122-targeting antibody for celiac disease, and expects preliminary Phase 1b gluten challenge data in the fourth quarter of 2026
• ▪Argenx acquired Forte Biosciences for $2.2 billion to obtain an antibody designed to block CD122, a subunit of the IL-2 and IL-15 receptors, which is a potential competitor to TEV-53408

Royalty Pharma funding agreement

• ▪Under the 2026 funding agreement, Teva Pharmaceutical Industries will owe Royalty Pharma a milestone payment and global sales royalties if TEV-53408 is approved and commercialized
• ▪Teva Pharmaceutical Industries secured a funding agreement with Royalty Pharma in early 2026 that provides up to $500 million to support the clinical development of TEV-53408

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