Saturday, April 20, 2024

Roche Agrees to Acquire Telavant and Innovative TL1A Antibody (RVT-3101) for Inflammatory Bowel Disease from Roivant

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Roche has entered into a definitive agreement to acquire Telavant Holdings, Inc., a subsidiary of Roivant Sciences Ltd. and Pfizer Inc. This acquisition includes the rights to develop, manufacture, and commercialize RVT-3101 in the United States and Japan for the treatment of inflammatory bowel disease (IBD) and potentially other diseases. The purchase price for the acquisition is $7.1 billion upfront, with a near-term milestone payment of $150 million.

RVT-3101 is a novel TL1A-directed antibody that has shown promise in the treatment of IBD, including ulcerative colitis and Crohn’s disease. IBD is a group of chronic gastrointestinal disorders that affect nearly 8 million people worldwide. The antibody’s innovative mode of action, targeting both inflammation and fibrosis, suggests its potential application in multiple other diseases.

The drug candidate RVT-3101 has undergone Phase 2b clinical trials, known as the TUSCANY-2 study, in patients with moderate to severe ulcerative colitis. In this global, randomized, double-blinded, placebo-controlled trial involving 245 patients, RVT-3101 demonstrated positive results during the maintenance treatment phase. This phase showed improvements in clinical remission (36% at week 56) and endoscopic improvement (50% at week 56) at the proposed Phase 3 dose administered subcutaneously every month. Additionally, RVT-3101 exhibited a favorable safety profile during the maintenance dosing period.

This acquisition allows Roche to advance RVT-3101 and potentially offer a groundbreaking therapy for patients with IBD, as well as explore its potential in other diseases. The company is committed to initiating a global Phase 3 trial for RVT-3101 as soon as possible.

In addition to gaining rights to RVT-3101, Roche also secures an option to collaborate with Pfizer on a next-generation p40/TL1A-directed bispecific antibody, currently in Phase 1 development. The transaction is subject to customary closing conditions and is expected to close in either Q4 2023 or Q1 2024.

Roche is determined to transform the treatment landscape for IBD patients, focusing on offering effective therapies and improving the convenience of administration for patients, particularly through subcutaneous delivery. This acquisition reflects Roche’s commitment to advancing innovative solutions and enhancing patient outcomes for various medical conditions.

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