Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE) announced on September 8, 2026, that its collaborator Novartis AG has initiated a Phase 2 clinical study for the company's VAV1-directed molecular glue degrader, MRT-6160 (DDY391), in participants with Sjögren’s disease. The study is a randomized, double-blind, placebo-controlled, multi-center trial designed to evaluate the efficacy, safety, and tolerability of the investigational drug over up to 52 weeks to support dose selection for Phase 3.
In connection with the first patient visit of this study, Monte Rosa will receive a $50 million milestone payment from Novartis. This payment is triggered by the initiation of the first Phase 2 study under the companies' global exclusive development and commercialization license agreement.
Under the terms of the Novartis Agreement, Novartis holds exclusive worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1-directed molecular glue degraders. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon the initiation of Phase 2 studies. The agreement stipulates that Novartis is responsible for conducting and funding Phase 2 studies, while Monte Rosa will co-fund Phase 3 clinical development and share 30% of profits and losses related to manufacturing and commercialization in the U.S.
MRT-6160 (DDY391) is a potent, highly selective, and orally bioavailable investigational molecular glue degrader targeting VAV1, a key signaling protein. Preclinical and clinical data indicate that the compound can degrade VAV1 by greater than 90% in peripheral blood T cells and suppress key inflammatory biomarkers, with administration generally well tolerated and no serious adverse effects observed in Phase 1.
