Monte Rosa plans to begin Phase 1 trial of MRT-6160 in mid-2024

Findings expected to support future Phase 2 studies of several diseases

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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Monte Rosa Therapeutics is planning to initiate a Phase 1 clinical trial to test MRT-6160, its investigational therapy for multiple sclerosis (MS) and other autoimmune diseases, by mid-2024.

The trial will follow the submission of an investigational new drug (IND) application, a formal request to U.S. regulatory authorities to start testing a new therapy in people, which the company plans to file in the first half of the year.

This Phase 1 trial will investigate ascending doses of the experimental therapy, given once or multiple times, in healthy volunteers. Its findings are expected to support future proof-of-concept Phase 2 studies that will test MRT-6160 in several autoimmune diseases.

“MRT-6160 is anticipated to enter a Phase 1 healthy volunteer study this year with the aim to move efficiently into early proof-of-concept studies in patients across multiple autoimmune indications,” Markus Warmuth, MD, Monte Rosa’s CEO, said in a company press release.

Autoimmune diseases are caused by the body’s immune system mistakenly attacking its own cells and tissues. In most cases, this attack is mediated by two immune cell types, called B-cells and T-cells.

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How does MRT-6160 work?

MRT-6160 is a molecular glue degrader (MGD) designed to target the VAV1 protein, which is required for the proper function of B- and T-cells, and promote its degradation. The therapy works to help physically connect the target protein to proteins involved in the cells’ natural protein degradation mechanisms.

By helping VAV1 get marked for degradation and be destroyed, MRT-6160 should lower the pro-inflammatory activity of B- and T-cells, reducing the inflammatory damage that contributes to the progression of autoimmune diseases.

This effect has been observed in preclinical studies where targeting VAV1 for degradation using an MGD caused a significant decrease in the proteins involved in inflammation. The approach also slowed disease progression in animal models of autoimmune conditions, supporting the rationale for developing MRT-6160.

“2023 was an exciting and highlight-filled year for Monte Rosa Therapeutics, including … advancement of our VAV1-targeted MGD” into studies that will support an IND application, Warmuth said.

The planned Phase 1 study will test single and multiple ascending doses of MRT-6160 in healthy volunteers. In single ascending dose studies, a small group of healthy volunteers receives a single dose of the study drug, which is increased in further groups until the maximum protocol-defined dose is reached or unacceptable side effects appear. In a multiple ascending dose part, participants receive multiple administrations of the drug at a given dose and subsequent groups receive higher doses.