MiRagen launches second phase of clinical trial for fibrosis drug

BOULDER — MiRagen Therapeutics Inc., a clinical-stage biopharmaceutical company focused on RNA-targeted therapies, is initiating a Phase 2 clinical trial.

The trial will evaluate the use of MRG-201 in subjects with a predisposition for keloid formation. Boulder-based MiRaten is developing MRG-201, which is a synthetic mimic of microRNA-29, for the treatment of patients with fibrotic diseases.

“We believe advancing MRG-201 into a Phase 2 clinical trial in subjects with a predisposition for keloid formation is an exciting opportunity to build on the Phase 1 data in induced cutaneous fibrosis, where MRG-201 reduced scar-tissue deposition in healthy human volunteers,” miRagen’s  president and CEO William S. Marshall said in a prepared statement. “Keloids are benign growths that form when scar tissue grows excessively after skin is injured. The lesions can be disfiguring and are often itchy and painful, which can lead to decreased quality of life for patients. We are encouraged by MRG-201’s potential to serve as a therapeutic option for those experiencing various types of pathological fibrosis.”

The Phase 2 trial will enroll about 12 subjects with a predisposition to keloid formation at multiple clinical sites in the United States. It will be a double-blind study with a random design. Subjects will receive small, matching wounds that will be sutured and injected with either MRG-201 or a placebo. The lesions will be observed for up to 12 months to determine the presence or absence of keloids.