MSD's TL1A drug tulisokibart delivers in pivotal IBD trial
MSD's tulisokibart has become the first anti-TL1A antibody to help patients with a type of inflammatory bowel disease (IBD) achieve clinical remission in a phase 3 trial.
The drug – which MSD acquired as part of its $10.8 billion takeover of Prometheus Biosciences in 2023 – is a key pipeline for MSD that analysts have predicted could bring in $4 to $5 billion in peak sales.
In the pivotal ATLAS-UC induction only trial, known as Study 2, tulisokibart (MK-7240) was able to achieve a significant improvement in clinical remission rates in patients with moderate to severe ulcerative colitis (UC), measured using the Modified Mayo Score (MMS), compared to placebo at 12 weeks.
It also improved secondary measures in the study, which looked at endoscopic improvement, clinical response per MMS, and histologic-endoscopic mucosal improvement, according to MSD, which is known as Merck & Co in the US and Canada.
MSD is also running a combined induction and maintenance dosing study within ATLAS-UC, called Study 1, which will need to generate results before MSD can submit tulisokibart to regulatory authorities for approval. It expects to report data from both studies at a forthcoming medical congress.
TL1A – or tumour necrosis factor-like ligand 1A – has become a hot topic in immunology and inflammation R&D, with tulisokibart in front by a nose in a race to market alongside candidates like Teva/Sanofi's duvakitug and Roche's afimkibart, which are also in the final stages of clinical testing.
Other companies looking at the target include Spyre Therapeutics with phase 2 candidate SPY002, along with Earendil Labs, Boehringer Ingelheim, Caldera Therapeutics, and AbbVie/FutureGen, amongst others, with projects in early development.
"These positive Phase 3 induction results for tulisokibart are the first for an anti-TL1A biologic," said Eliav Barr, chief medical officer at Merck Research Laboratories.
"They represent an important step forward for patients with moderately to severely active ulcerative colitis who – despite available treatments – continue to experience symptoms, and do not achieve clinical remission," he added.
"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 ulcerative colitis."
Reflecting tulisokibart's importance to MSD's sales growth in the coming years, MSD is running what it says is the "broadest development programme in the novel anti-TL1A class."
Phase 3 studies are underway in Crohn's disease (ATLAS-CD), as well as phase 2 trials in systemic sclerosis-associated interstitial lung disease, rheumatoid arthritis, psoriatic arthritis, radiographic axial spondyloarthritis, and hidradenitis suppurativa.
