Teva Pharmaceutical Industries (TEVA) Study result summary

Program Overview, Study Design, and Disease Context

• Duvakitug is a potent, selective human IgG1 monoclonal antibody targeting TL1A-DR3 signaling, designed for ulcerative colitis (UC) and Crohn's disease (CD), aiming to address significant unmet needs in these chronic conditions affecting up to 4.9 million globally.

• The phase IIb study included a 14-week induction phase and a 44-week maintenance phase, with responders re-randomized to 450 mg or 900 mg every four weeks.

• The study used a randomized, double-blind, dose-ranging basket design for both UC and CD, enrolling 130 patients who responded to induction.

• Subcutaneous dosing was used throughout, with a prefilled syringe compatible with an auto-injector planned for phase III.

• The phase III program (Sunscape for UC, Starscape for CD) is underway with rapid enrollment and robust design.

Key Efficacy and Safety Results

• Induction phase showed robust placebo-adjusted response rates: 27.4% delta in UC and 34.8% in CD, with clear dose response.

• At week 44, 58% (900 mg) and 47% (450 mg) of UC patients achieved clinical remission; for CD, 55% (900 mg) and 41% (450 mg) achieved endoscopic response.

• Durable efficacy was observed for nearly one year in both UC and CD responders, regardless of prior advanced therapy exposure.

• Safety profile was favorable, with low anti-drug antibody rates (3%-5%), no dose-dependent adverse events, and most common adverse events being upper respiratory tract infection, nasopharyngitis, Crohn's disease, and hypertension.

• Efficacy is competitive with other TL1As, IL-23s, and JAK inhibitors, with potential to be best in disease.

Mechanism, Development Status, and Strategic Collaboration

• Duvakitug blocks TL1A-DR3 signaling while sparing DCR3 binding, potentially reducing inflammation and fibrosis in IBD.

• Developed in collaboration with Sanofi, with Teva and Sanofi sharing worldwide R&D costs and profits 50:50, and co-commercialization agreements.

• Sanofi leads phase III development; Teva leads commercialization in Europe and select countries, Sanofi in North America, Japan, and other regions.

• The safety and efficacy of duvakitug have not been reviewed by regulatory authorities.

• The program is exploring combination therapies, bispecifics, and biomarker-enriched populations, with potential for additional indications beyond UC and CD.