Merck & Co starts phase IIb study of tulisokibart in rheumatoid arthritis

[Credit: Michael Vi / Shutterstock.com].

Merck & Co has expanded its clinical development programme for tulisokibart (MK-7240), adding phase IIb trials for a trio of immune-mediated inflammatory diseases.

The monoclonal antibody, which is currently in late-stage trials for conditions such as ulcerative colitis and Crohn’s disease, will now see its development in rheumatoid arthritis, hidradenitis suppurativa and radiographic axial spondyloarthritis advanced.

Global recruitment for the three new phase IIb studies is underway with a target of enrolling more than 640 patients between them.

Dr Aileen Pangan, Vice President and Head of Immunology, Global Clinical Development at Merck Research Laboratories, said: “The expansion of our tulisokibart clinical development programme reflects Merck’s ongoing commitment to addressing the burden of immune-mediated inflammatory diseases.

“We’re excited to further evaluate the potential of tulisokibart as a treatment for patients across multiple diseases in rheumatology and dermatology.”

Merck & Co, known as MSD outside the US and Canada, gained tulisokibart through its $11 billion acquisition of Prometheus Biosciences in 2023 as part of moves to diversify its portfolio for a looming post-Keytruda future. Merck’s blockbuster cancer drug Keytruda is expected to see key patents expire in 2028 and 2031, opening up the threat of biosimilar competition first in the US and then in Europe.

Tulisokibart is an investigational humanised monoclonal antibody that targets tumour necrosis factor (TNF)-like cytokine 1A (TL1A), which is associated with both intestinal inflammation and fibrosis.

The drug is being studied in phase III studies in inflammatory bowel disease (IBD), ulcerative colitis and Crohn’s disease, as well as a phase II trial in systemic sclerosis-associated interstitial lung disease.

Further complementing its ‘pipeline in a product’ strategy, the new phase IIb clinical trials will cover moderate to severe hidradenitis suppurativa, radiographic axial spondyloarthritis and rheumatoid arthritis.

Competitors in the TL1A space include Roche’s RVT-3101, AbbVie/FutureGen Biopharmaceutical’s FG-M701 and Sanofi/Teva’s duvakitug.