Novartis Initiates Second Phase 2 Study for MRT-6160 in Psoriatic Arthritis

BOSTON, Oct. 28, 2026 /CourierPR/ -- Monte Rosa Therapeutics, a clinical-stage biotechnology company, announced the initiation of a second Phase 2 clinical study for its investigational molecular glue degrader MRT-6160 (DDY391) in people living with active moderate to severe psoriatic arthritis (PsA). This study, part of a global exclusive development and commercialization license agreement between Monte Rosa and Novartis, follows the Phase 2 trial in Sjögren's disease that was initiated in August.

The study will evaluate the efficacy, safety, tolerability, and dose-response relationship of MRT-6160 (DDY391) in participants with active moderate to severe PsA. More information about the study can be found at ClinicalTrials.gov, with the study identifier: NCT07801495.

MRT-6160 (DDY391) is a potent, highly selective, and orally bioavailable investigational molecular glue degrader of VAV1, a key signaling protein downstream of both the T- and B-cell receptors. Preclinical and clinical data support the potential of MRT-6160 (DDY391) to address multiple immune-mediated diseases. In a Phase 1 study, MRT-6160 (DDY391) demonstrated sustained, dose-dependent VAV1 degradation of greater than 90% in peripheral blood T cells after single- and multiple-dose administration, as well as suppression of key inflammatory biomarkers. The administration of MRT-6160 (DDY391) was generally well tolerated, with no serious adverse effects observed.

Psoriatic arthritis is a chronic, progressive inflammatory disease that affects approximately 0.1% to 0.2% of the general population or up to 50 million people worldwide. It is part of a family of lifelong inflammatory diseases (spondyloarthritis) that target the joints and is closely associated with psoriasis. Up to 40% of patients with psoriasis may develop PsA.

Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE) is developing novel molecular glue degrader (MGD)-based medicines for patients living with serious diseases. The company has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160. Under the terms of the agreement, Novartis has exclusive worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1 MGDs and is responsible for all clinical development and commercialization, starting with Phase 2 clinical studies. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

This development milestone marks a significant step in the advancement of MRT-6160 (DDY391) and demonstrates the strong momentum behind the collaboration between Monte Rosa and Novartis.

The company's pipeline includes multiple programs in the clinic, spanning autoimmune and inflammatory diseases, oncology, and beyond. Monte Rosa's QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity.