Novartis has initiated a Phase 2 clinical study of MRT-6160, also known as DDY391, an orally bioavailable investigational molecular glue degrader of VAV1, a signaling protein downstream of T-cell and B-cell receptors. The trial is being conducted for Sjögren's disease, an autoimmune condition that affects approximately 0.25% of the population and is described as the second most prevalent rheumatic autoimmune disease. The condition can affect multiple organs and is associated with symptoms including dryness, fatigue and pain.
The study is a Phase 2a/b randomized, double-blind, placebo-controlled, multi-center trial in which patients may receive up to 52 weeks of treatment with MRT-6160. It is intended to evaluate the drug candidate's efficacy, safety and tolerability, and to support dose selection for potential Phase 3 development. The trial is the first of several planned evaluations of MRT-6160 across immune-mediated diseases under a global exclusive license agreement. It is registered on ClinicalTrials.gov under identifier NCT07737743.
Under the agreement with Monte Rosa Therapeutics, listed on Nasdaq under GLUE, the company will receive a $50 million milestone payment tied to the first patient visit in the study. Monte Rosa is also eligible for up to $2.1 billion in development, regulatory and sales milestones. The company will co-fund Phase 3 clinical development and share 30% of the profits and losses associated with manufacturing and commercialization in the United States, in addition to receiving tiered royalties on net sales outside the U.S.
Earlier Phase 1 data for MRT-6160 showed sustained, dose-dependent VAV1 degradation of more than 90% in peripheral blood T cells after single and multiple-dose administration. The candidate was reported as generally well tolerated, with no serious adverse effects observed.
