BOSTON, Massachusetts — September 8, 2026
Monte Rosa Therapeutics, Inc. announced that Novartis has initiated a global Phase 2 clinical study of MRT-6160 (DDY391), a VAV1-directed molecular glue degrader being developed for Sjögren’s disease. The milestone triggers a $50 million payment to Monte Rosa from Novartis based on the first patient visit in the Phase 2 study and represents a major advancement under the companies’ global exclusive development and commercialization agreement. Novartis is responsible for conducting and funding Phase 2 development, while Monte Rosa remains eligible for additional milestone payments as further Phase 2 studies begin. The collaboration gives Novartis worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1-directed molecular glue degraders, positioning the program as a significant partnered asset within Monte Rosa’s pipeline.
Novartis Leads Phase 2 Development of VAV1 Degrader
The new Phase 2a/b study is designed to evaluate MRT-6160 for up to 52 weeks in participants with Sjögren’s disease, with efficacy, safety and tolerability assessments intended to support future dose selection for Phase 3 development. The randomized, double-blind, placebo-controlled, multicenter study represents the first of several clinical studies expected for MRT-6160 under the Novartis collaboration. The program is particularly relevant to Sjögren’s disease because VAV1 is a key signaling protein downstream of both T-cell and B-cell receptors, providing a biological rationale for targeting immune pathways involved in the disease. Monte Rosa is using the Phase 2 initiation to advance its molecular glue degrader platform through a large pharmaceutical partnership while Novartis assumes responsibility for the clinical development program beginning with Phase 2
MRT-6160 Builds on Clinical and Molecular Glue Data
MRT-6160 is an oral, highly selective molecular glue degrader designed to eliminate VAV1, with Monte Rosa developing the program through its proprietary QuEEN™ discovery engine. In a Phase 1 study, the investigational therapy demonstrated more than 90% sustained, dose-dependent VAV1 degradation in peripheral blood T cells following single and multiple doses, together with suppression of key inflammatory biomarkers. The company reported that MRT-6160 was generally well tolerated in the Phase 1 study, with no serious adverse effects observed. These findings provide the clinical foundation for continued development in immune-mediated diseases and support the company’s broader strategy of using molecular glue degraders to address disease-driving proteins that have historically been difficult to target with conventional therapeutic approaches.
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Monte Rosa Eligible for Up to $2.1 Billion in Milestones
The Phase 2 launch strengthens the financial and strategic value of Monte Rosa’s partnership with Novartis, which includes potential development, regulatory and sales milestones of up to $2.1 billion. Monte Rosa will also co-fund any Phase 3 clinical development and is eligible to share 30% of profits and losses associated with U.S. manufacturing and commercialization of MRT-6160, alongside tiered royalties on ex-U.S. net sales. Novartis is responsible for Phase 2 clinical development and commercialization activities, allowing Monte Rosa to advance the program while leveraging the resources of a global pharmaceutical partner. Additional Phase 2 studies are expected to evaluate MRT-6160 across other immune-mediated diseases, potentially generating further development milestones. The milestone therefore represents more than a single clinical event, reinforcing Monte Rosa’s partnered development strategy and providing an important validation point for its molecular glue technology platform..
Source: Monte Rosa Therapeutics press release
