Roche Acquires Telavant and TL1A Antibody for Inflammatory Bowel Disease

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• Roche will gain the rights to develop, manufacture and commercialise RVT-3101 in the US and Japan for the treatment of inflammatory bowel disease and potentially multiple other diseases
• RVT-3101 is a Phase 3-ready antibody with first-in-class and best-in-disease potential, a novel mode of action and strong Phase 2b data in ulcerative colitis
• Roche will also obtain an option to enter into a global collaboration with Pfizer on a next-generation p40/TL1A directed bispecific antibody, currently in Phase 1
• Under the terms of the agreement, Roche will pay a purchase price of US$ 7.1 billion upfront and a near-term milestone payment of US$ 150 million

 The agreement includes the development, manufacturing and commercialisation rights in the US and Japan for Telavant’s RVT-3101, a novel TL1A directed antibody. RVT-3101 is a promising new therapy in development for people suffering from inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. Inflammatory bowel disease is a group of chronic gastrointestinal disorders with almost 8 million people diagnosed worldwide and 80% of all individuals not experiencing lasting remission.¹ Given the antibody’s novel mode of action targeting both inflammation and fibrosis, it has potential to be applied in multiple other diseases.

RVT-3101 has been investigated in the TUSCANY-2 phase 2b study in patients with moderate to severe ulcerative colitis. The global, randomised, double-blinded, placebo controlled trial delivered the first long-term, dose finding data in a large number of patients (n=245). The maintenance treatment phase following induction resulted in improved clinical remission (36% at week 56) and endoscopic improvement (50% at week 56) at the proposed Phase 3 dose administered subcutaneously every month. Beyond the efficacy results, the maintenance dosing period of RVT-3101 also showed a favourable safety profile across all patients.

“We strongly believe this novel TL1A directed antibody has the transformational potential to make a significant difference for patients living with inflammatory bowel disease and potentially other diseases,” said Thomas Schinecker, CEO Roche Group. “We are excited to add this promising new therapy in development to our portfolio and to make it available to patients as quickly as possible.”

“The recent Phase 2b for RVT-3101 delivered the first long-term, robust dataset demonstrating improved clinical remission in the maintenance treatment phase,” says Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “Given this promising data, we believe that RVT-3101 has the potential to be the first therapy that offers both high efficacy and safety for people with inflammatory bowel disease and the convenience of an at-home, subcutaneous administration."