BOULDER, Colorado, – November 12, 2015 – miRagen Therapeutics, Inc. a biopharmaceutical company developing innovative microRNA-based therapeutics, today announced that it has initiated a Phase 1 clinical study of MRG-201, a synthetic microRNA mimic (promiR) to microRNA-29b. The Phase 1 trial is being conducted in normal healthy volunteers and may be extended to patients suffering from cutaneous scleroderma.
“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 William Marshall, Chief Executive Officer of miRagen. “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.”
“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,” added 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.”
Scientists at miRagen working in collaboration with researchers led by Eric N. Olson, Ph.D. at the University of Texas Southwestern Medical Center were the first to identify the role that appears to be played by microRNA-29 in pathological fibrosis in animal models and MRG-201 has previously demonstrated reversal of fibrosis in a mouse model of pulmonary fibrosis. The Company, in collaboration with investigators at Yale University is in the second year of a Centers for Advanced Diagnostics and Experimental Therapeutics grant from the National Institutes of Health to explore the development of MRG-201 for the treatment for progressive lung fibrosis.
MicroRNAs have emerged as an important class of small RNAs encoded in the genome, acting as master regulators of gene expression. Recent studies have indicated that microRNAs appear to be associated with many disease processes. Because they are thought to be single molecular entities that dictate the expression of fundamental regulatory pathways, microRNAs represent potential drug targets for controlling many biologic and disease processes.1
About MRG-201 and microRNA-29
MRG-201 is a promiR (agonist) to microRNA-29b. The microRNA-29 family is a well-established negative regulator of a wide variety of genes important in extracellular matrix deposition. The expression of the three family members is consistently down-regulated in a number of pathological fibrotic conditions, including cardiac, renal, hepatic, and pulmonary fibrosis, as well as systemic sclerosis. Numerous studies in cell-culture and genetic replacement in rodents have also demonstrated the potential of miR-29 normalization to correct many drivers of pathological fibrosis.
About miRagen Therapeutics, Inc.
miRagen Therapeutics, Inc., is a biopharmaceutical company focused on the discovery and development of innovative microRNA (miRNA)-targeting therapies in disease areas of high unmet medical need. The Company seeks to leverage in-house expertise in miRNA biology, oligonucleotide chemistry, and drug development to evaluate and advance promising technologies and high-potential product candidates for its own pipeline and in conjunction with strategic collaborators. For certain cardiovascular disease programs, miRagen has a collaboration and license agreement with Servier, an independent French research-based pharmaceutical company. miRagen retains all rights for the Servier-partnered programs in the U.S and Japan.
For more information, please visit www.miragenrx.com.
For information on clinical trials please visit www.clinicaltrials.gov.
Safe Harbor Statement
This press release contains “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the role of microRNAs in disease processes and as potential drug products, the potential for MRG-106 and MRG-201 to target diseases, the adequacy of the Company’s capital to support its future operations and the Company’s ability to successfully initiate and complete clinical trials. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process, the risks and uncertainties associated with: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; and, the impact of competitive products and technological changes. The Company disclaims any intent or obligation to update these forward-looking statements
Kecia Carroll, Communications
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