Teva Presents New Data Supporting Safety, Tolerability and Target Engagement of Anti-TL1A (TEV-‘574) Antibody at the 2024 ECCO Annual Meeting

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced positive safety, tolerability, and pharmacokinetic data for its anti-TL1A (TEV-’574) asset, a potentially best-in-class human IgG1 monoclonal antibody that targets the tumor necrosis factor (TNF)-like ligand 1A (TL1A) and is designed to offer both anti-inflammatory and anti-fibrotic effects.^1-3

The data show the rapid and sustained suppression of free TL1A, confirming the target engagement of anti-TL1A (TEV-’574), and show a well-tolerated safety profile in patients with asthma, which support continued clinical investigation for moderate-to-severe inflammatory bowel disease (IBD); this includes ulcerative colitis (UC) and Crohn's disease (CD).^1-3 These findings will be presented at the 19th Annual Congress of the European Crohn’s and Colitis Organisation (ECCO), which takes place February 21-24, 2024, in Stockholm, Sweden.

“These results from the first-in-human trials of anti-TL1A (TEV-’574) are exciting because they show that it effectively engages with the TL1A target, supports its safety profile and is well-tolerated. This aligns with our extensive pre-clinical evidence and further supports ongoing clinical investigations of anti-TL1A (TEV-’574) in IBD, where TL1A plays a prominent role in amplification of immune response leading to burdensome inflammation and fibrosis in the gastrointestinal tract,” said Dr. Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “We are currently investigating the efficacy and safety of anti-TL1A (TEV-’574) in IBD through the RELIEVE UCCD Phase 2 trial, which features an innovative and efficient basket study design allowing the inclusion of patients with either type of IBD (ulcerative colitis and Crohn’s disease). These data reinforce the potential for anti-TL1A (TEV-’574) to become a novel treatment option for IBD and solidifies our ongoing commitment to provide innovative medicines to improve the lives of people living with IBD, as quickly as possible.”

First-in-human pharmacokinetic and safety data for anti-TL1A (TEV-'574) from a Phase 1 study in healthy volunteers and patients with mild asthma and a Phase 2 study in patients with severe asthma show:

• Dose-proportional increases in anti-TL1A (TEV-’574) exposure and minimal accumulation after multiple dosing every two weeks.¹
• A rapid and prolonged decrease in free TL1A levels indicating successful target engagement. This decrease was sustained up to two months after the last dose despite low or undetectable anti-TL1A (TEV-'574) levels.¹
• A favorable safety profile and well tolerated up to doses of 2300mg.^1,2

Also to be presented at ECCO 2024 is the study design of the RELIEVE UCCD Phase 2 trial investigating the efficacy and safety of anti-TL1A (TEV-’574) in patients with moderate-to-severe UC or CD.³ This first-ever basket study design for an IBD trial offers an efficient approach to help advance anti-TL1A (TEV-’574) to Phase 3 studies.