MSD’s confidence in its anti-TL1A antibody tulisokibart in inflammatory diseases has been made apparent by a decision to start trials of the drug in three more indications.
Already in phase 3 testing for ulcerative colitis and Crohn’s disease and phase 2 for systemic sclerosis-associated interstitial lung disease (SSc-ILD), MSD has now started a trio of new phase 2b studies in rheumatoid arthritis, ankylosing spondylitis, and hidradenitis suppurativa.
TL1A – or tumour necrosis factor-like ligand 1A – has become something of a hot topic in immunology and inflammation R&D, with tulisokibart competing with candidates in development at Teva/Sanofi and Roche to be first to market.
MSD – known as Merck & Co in the US and Canada – acquired tulisokibart when it took over Prometheus Biosciences for $10.8 billion in 2023, and analysts have suggested peak sales of the drug could be in the region of $4 to $5 billion a year.
Roche’s entry into the category with afimkibart (RG6631) stemmed from its purchase of Telavant for $7.1 billion, and since then it has advanced the drug into a phase 3 programme, also in inflammatory bowel disease (IBD), with earlier-stage studies on the go in atopic dermatitis and metabolic dysfunction-associated steatohepatitis (MASH).
Meanwhile, Sanofi licensed rights to Teva’s duvakitug in a deal valued at around $1.5 billion, and the two partners have reported positive phase 2b results with the drug in ulcerative colitis and Crohn’s and are recruiting for a four-study phase 3 programme.
Looking further back in development, AbbVie also recently entered the category via a deal worth up to $1.7 billion with FutureGen for an anti-TL1A antibody still in preclinical development, while Spyre Therapeutics is running early-stage trials of a pair of extended half-life TL1A antibodies (SPY002 and SPY072), and Absci recently started dosing patients in a phase 1 trial of its AI-designed candidate ABS-101.
“The expansion of our tulisokibart clinical development program reflects Merck’s ongoing commitment to addressing the burden of immune-mediated inflammatory diseases,” said Dr Aileen Pangan, head of immunology, global clinical development, at Merck Research Laboratories.
“We’re excited to further evaluate the potential of tulisokibart as a treatment for patients across multiple diseases in rheumatology and dermatology,” she added.
The new phase 2b trials have already started recruiting patients, with a target headcount of 640, with results expected from 2027 onwards.
Image by Theodor Moise from Pixabay
