Novartis starts Phase 2 trial of Monte Rosa's MRT-6160 in Sjögren's disease

Monte Rosa Therapeutics said on September 8, 2026 that its partner Novartis has begun a Phase 2 clinical study of MRT-6160, also known as DDY391, a molecular glue degrader targeting VAV1, in patients with Sjögren's disease. Monte Rosa describes Sjögren's disease as the second most prevalent rheumatic autoimmune disease.¹

The first patient visit in the study triggers a $50 million milestone payment from Novartis to Monte Rosa.¹ The trial is a Phase 2a/b, randomized, double-blind, placebo-controlled, multi-center study testing up to 52 weeks of MRT-6160 (DDY391) treatment to inform dose selection for a future Phase 3 program, titled "A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease" and listed under ClinicalTrials.gov identifier NCT07737743.¹

MRT-6160 (DDY391) is described as a potent, highly selective, orally bioavailable molecular glue degrader that acts on VAV1, a signaling protein downstream of both T-cell and B-cell receptors.¹ In an earlier-stage study, the drug produced consistent, dose-related reductions in VAV1 levels exceeding 90% in circulating T cells following both single and repeated dosing, along with reduced levels of inflammatory markers, and was generally well tolerated with no serious adverse events reported.¹

Under the companies' agreement, Novartis holds exclusive global rights to develop, manufacture, and commercialize MRT-6160 and related VAV1 degraders, and is responsible for clinical development and commercialization starting with Phase 2 work.¹ Monte Rosa can earn as much as $2.1 billion in additional development, regulatory, and sales-related payments tied to Phase 2 progress and beyond.¹ Monte Rosa will help fund any Phase 3 work and is entitled to 30% of U.S. profits and losses from the drug, plus royalties on sales outside the U.S.¹