Monte Rosa Therapeutics (NASDAQ:GLUE) announced that the first participant has been dosed in its Phase 1 healthy volunteer study evaluating MRT-6160, a VAV1-directed MGB being developed for systemic and neurological autoimmune diseases.
The company anticipates initial data from its Phase 1 study in Q1 2025, followed by the initiation of proof-of-concept studies in ulcerative colitis, rheumatoid arthritis, and potentially other indications.
In a statement, Markus Warmuth, M.D., and CEO of Monte Rosa, said, “We are very pleased to initiate our Phase 1 clinical study of MRT-6160, a potent, highly selective, and orally bioavailable VAV1-directed MGD, which we believe is the first rationally designed MGD in clinical development for a non-oncology indication.”
“Our MGD-based therapeutic approach is well suited to degrade proteins that have been challenging to address with conventional modalities, and we believe we have opportunities to apply our technology to well-characterized targets like VAV1 that were previously considered undruggable,” Dr. Warmuth said.
“By degrading VAV1, a key regulator of T- and B-cell receptor activity, MRT-6160 could offer a differentiated approach to treat multiple autoimmune and inflammatory diseases. The Phase 1 study of MRT-6160 is designed to provide early insights into safety, pharmacokinetics, VAV1 protein degradation, and key downstream pharmacodynamic markers including CD69, IL-2, IL-6, and IL-17, helping to further inform our clinical strategy,” he added.
