Chugai gains Japan rights to Roche’s anti-TL1A IBD drug

Roche's Chugai Pharmaceutical division has finalized a licensing agreement to obtain Japanese rights to the Swiss pharmaceutical company's experimental anti-TL1A antibody, RG6631. This antibody is being developed for the treatment of inflammatory bowel diseases (IBD), such as ulcerative colitis and Crohn’s disease. Under the agreement, Chugai will have exclusive rights to develop and market RG6631 in Japan. Roche will receive an upfront payment and milestone payments, though the details of these payments have not been disclosed.

Chugai CEO Osamu Okuda emphasized the significant unmet treatment needs for these challenging conditions and stated that Chugai will collaborate closely with Roche to ensure that RG6631 reaches patients with ulcerative colitis and Crohn’s disease as quickly as possible. Chugai highlighted RG6631’s unique mechanism of action, which targets inflammation and fibrosis through TL1A inhibition. This approach could offer a new therapeutic option not only for IBD but potentially for other conditions as well.

Chugai reported that RG6631 has shown substantial improvements in key endpoints, including clinical remission, during both the induction and maintenance phases of the global TUSCANY-2 Phase II study involving patients with moderate-to-severe ulcerative colitis. Roche is expected to commence a Phase III study by the end of the year. Additionally, a second Phase II study involving patients with moderate-to-severe Crohn’s disease is currently underway.

The anti-TL1A space is highly competitive, with several companies vying for dominance in the IBD market. AbbVie recently acquired global rights to FutureGen's preclinical candidate FG-M701 for $150 million upfront. Additionally, Teva and Sanofi have joined forces on another anti-TL1A antibody, duvakitug (TEV-48574), targeting moderate-to-severe ulcerative colitis and Crohn’s disease. The topline data from their mid-stage trials are expected in the last quarter of this year.

Other significant transactions in this space include Roche's acquisition of Roivant's Telavant (RVT-3101) for $7.1 billion following positive mid-stage data in ulcerative colitis. Merck & Co. also expanded its anti-TL1A portfolio by acquiring tulisokibart (MK-7240) through its $10.8 billion purchase of Prometheus.

Overall, the competition and strategic partnerships in the anti-TL1A space underscore the high stakes and potential for groundbreaking treatments in the IBD market. Roche and Chugai's collaboration on RG6631 could pave the way for new advancements and improved patient outcomes in Japan and potentially beyond.