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 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. Read more HERE...