MSD’s investigational humanised monoclonal antibody targeting tumour necrosis factor-like cytokine 1A (TL1A), which it acquired during a $10.8bn buyout of Prometheus Therapeutics, has met all its primary and secondary endpoints in a Phase III trial.
In the ATLAS-UC induction-only study (NCT06052059), tulisokibart showed significant improvements in patients with moderately to severely active ulcerative colitis (UC).
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The study successfully met its primary endpoint of clinical remission, as defined by the Modified Mayo Score (MMS), at week 12, as well as its key secondary endpoints.
Dr Eliav Barr, senior VP, head of global clinical development and CMO of MSD Research Laboratories, said: “These positive Phase III induction results for tulisokibart are the first for an anti-TL1A biologic. They represent an important step forward for patients with moderately to severely active UC who – despite available treatments – continue to experience symptoms, and do not achieve clinical remission. These results reinforce the potential of this novel approach designed to help address immuno-fibrosis, a key driver of chronic immune dysregulation and disease progression in UC.”
Results from the ATLAS-UC will be presented alongside data from the ongoing induction and maintenance study (NCT06651281) at an upcoming scientific congress and shared with regulatory authorities.
The drug was also found to be safe and well-tolerated in the study, with no new safety signals.
Tulisokibart has the broadest development programme in the novel anti-TL1A class and is currently being evaluated in seven disease indications. This includes a Phase III trial in Crohn’s disease (CD) ARES-CD (NCT06430801), and Phase II trials in systemic sclerosis-associated interstitial lung disease (SSc-ILD) (NCT05270668), rheumatoid arthritis (RA) (NCT07176390), psoriatic arthritis (PsA) (NCT07486960), radiographic axial spondyloarthritis (r-axSpA) (NCT07133633) and hidradenitis suppurativa (HS) (NCT06956235).
MSD signed the definitive agreement to take over clinical-stage biotechnology firm Prometheus Biosciences for $10.8bn in April 2023. The company bought all of Prometheus Biosciences’ outstanding shares for $200 a share through a subsidiary, with the deal completed in June 2023.
According to GlobalData, the UC market across the 68 markets (68M) will rise from $11.1bn in 2021 to $14.7bn in 2031.
GlobalData is the parent company of Clinical Trials Arena.
