Vera Pharmaceuticals and Sanofi are co-developing the anti-TL1A therapy for IBD. Image credit: Shutterstock / MMD Creative

Teva Pharmaceuticals and Sanofi have revealed new data that further bolsters their $1.5bn co-development deal of an anti-tumour necrosis factor-like ligand 1A (anti-TL1A) therapy.

The companies released data from a Phase I study in healthy volunteers and patients with mild asthma and Phase II trial in asthma showing that the anti-TL1A, TEV-’574, is targeting rapid and sustained suppression of free tumour necrosis factor-like ligand 1A (TL1A) and has a well-tolerated safety profile.

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TEV-’574 is a human Immunoglobulin G1 (IgG1) monoclonal antibody that targets the TL1A and is designed to offer both anti-inflammatory and anti-fibrotic effects.

The data supports continued investigations for moderate-to-severe inflammatory bowel disease (IBD) including ulcerative colitis (UC) and Crohn’s disease (CD).

Teva Pharmaceuticals and Sanofi announced they had completed a $1.5bn deal on November 30, 2023, to collaborate on the development and commercialisation of TEV-’574.

Teva will lead commercialisation of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialisation in North America, Japan, other parts of Asia and the rest of the world. Sanofi will be leading development of the Phase III program.

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Executive vice president of global research and development at Teva, Dr Eric Hughes said that the candidate is being investigated in IBD through the RELIEVE UCCD Phase IIb trial (NCT05499130).

The RELIEVE trial will be a 14-week randomised, double-blind, dose-ranging basket trial including patients with UC or CD. The trial is set to enrol 240 patients and will be completed in the first quarter of 2025, according to the ClinicalTrials.gov listing.

Anti-TL1A therapies in IBD

TL1A as a target for IBD has been popular since April 2023 when Merck acquired Prometheus Biosciences for approximately $10.8bn, to develop its anti-TL1A pipeline agent, PRA023 which now goes by MK-7240. This set a fire under the industry with the Sanofi and Teva agreement coming just months later. There has also since been an acquisition by Roche of Roivant’s anti-TL1A, RVT-3101, for $7.1bn which was finalised in December 2023.

TL1A plays a role in the immune response of T cells while promoting inflammation and fibrosis of intestinal mucosa. As a result, blocking this pathway with an anti-TL1A reduces inflammatory responses, making it an attractive treatment option for both IBD and asthma.