New Anti-Fibrotic Drug Candidate MRG-201 Enters Phase 1 Clinical Trial

New Anti-Fibrotic Drug Candidate MRG-201 Enters Phase 1 Clinical Trial
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miRagen Therapeutics, Inc., a biopharmaceutical company dedicated to the development of pioneering therapies based on microRNAs, recently announced the start of a Phase 1 clinical trial on the company’s product MRG-201 developed as a therapy for fibrotic conditions.

MicroRNAs (miRNAs) are small RNAs that act as master regulators of gene expression controlling key regulatory pathways. Their activity has been linked to several mechanisms in a disease context, making miRNAs possible therapeutic drug targets.

MRG-201 is a synthetic miRNA agonist (promiR) of microRNA-29b, which is a negative regulator of several genes involved in extracellular matrix deposition. It is known that miRNA-29b is down-regulated in fibrotic conditions, including pulmonary fibrosis, and studies in vitro and in rodent animal models have shown the potential of miRNA-29 normalization for correcting several factors contributing to pathological fibrosis. In a mouse model of pulmonary fibrosis in particular, MRG-201 was shown to be able to reverse fibrosis.

“As a Company dedicated to improving human health through the discovery and development of innovative RNA-targeting therapies like MRG-201, we are excited by this event,” said Dr. William Marshall, Chief Executive Officer of miRagen in a press release. “The initiation of this clinical trial advances a potentially important new therapy for patients suffering from pathological fibrosis and is an example of our focus on areas of high unmet medical need.”

The Phase 1 trial is planned to be conducted in healthy volunteers and perhaps also in patients with scleroderma, a fibrotic condition.

“We are excited to move MRG-201, our lead anti-fibrosis product candidate, into this first-in-human safety, tolerability and dose-range finding trial,” said Dr. David Rodman, Executive Vice President, R&D at miRagen. “This double-blind, placebo controlled trial is designed to lay the foundation for future clinical development of MRG-201 in cutaneous and other fibrotic diseases.”

Researchers at miRagen, together with a University of Texas Southwestern Medical Center team led by Dr. Eric N. Olson, where the first ones to report the involvement of miRNA-29 in pathological fibrosis in animal models. miRagen and their collaborators at Yale University are currently in the second year of a National Institutes of Health (NIH) grant – Centers for Advanced Diagnostics and Experimental Therapeutics grant – which goal is to develop MRG-201 as a therapy for progressive lung fibrosis.

Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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