Pfizer and Roivant Sciences have launched a new company focused on developing RVT-3101, a fully human monoclonal antibody targeting TL1A, for inflammatory and fibrotic diseases.
RVT-3101, which was originally developed by Pfizer, targets both inflammatory and fibrotic pathways by inhibiting TL1A, which has been shown to modulate the location and severity of inflammation and fibrosis.
The candidate has already been evaluated in an earlier phase 2 study – TUSCANY – in 50 patients, and is currently being evaluated in a large global phase 2b study – TUSCANY-2 – in 245 adult participants with moderate-to-severe ulcerative colitis (UC).
The new company, which has been created to develop these programmes, will be fully responsible for funding global development of RVT-3101 in UC and in additional inflammatory and fibrotic diseases and holds commercial rights in the US and Japan.
Pfizer, which will hold a 25% stake in the new business, will maintain commercial rights outside of the US and Japan.
“Our internally discovered antibody against TL1A, could potentially be the first agent to bring biomarker-selected precision medicine to people living with inflammatory bowel disease,” said Mikael Dolsten, Pfizer’s chief scientific officer, president, worldwide research, development and medical.
The new unit also has the exclusive option to collaborate with Pfizer on a next-generation TL1A directed antibody which recently entered phase 1.
Inflammatory bowel diseases, including UC and Crohn’s disease, affect around two million adults in the US. High rates of treatment failure mean that approximately 50% of patients are cycling off a given therapy within six to 12 months and are unlikely to achieve sustained remission, underscoring the need for new efficacious treatment options.
Mayukh Sukhatme, president and chief investment officer of Roivant, said: “We believe in RVT-3101’s potential to transform the inflammatory bowel disease landscape, which has long been in need of new, innovative therapies with greater efficacy.
“… TUSCANY-2 builds on the earlier TUSCANY data with many firsts for the class – TUSCANY-2 is the first study with subcutaneous efficacy data and the first dose-ranging study – and is among the largest phase 2b studies ever conducted in the indication. We are encouraged by the preliminary data and look forward to presenting the data and to seeing other results from the class.”