miRagen Therapeutics Announces Initiation of Phase 2 Clinical Trial of MRG-201

BOULDER, CO, USA I July 10, 2018 I miRagen Therapeutics, Inc. (NASDAQ:MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced the initiation of a Phase 2 clinical trial to evaluate MRG-201 in subjects with a predisposition for keloid formation. miRagen is developing MRG-201, a synthetic mimic of microRNA-29 for the potential 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,” said miRagen President and CEO William S. Marshall, Ph.D. “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.”

miRagen anticipates that the MRG-201 Phase 2 trial will enroll approximately 12 subjects that are historically predisposed to keloid formation after trauma to the skin at multiple clinical sites in the U.S.  The study will be a double-blinded, randomized design. Subjects will receive small, matching excisional wounds that will be sutured and then injected with either MRG-201 or placebo.  Thus, patients will serve as their own control, which will increase the statistical powering of the trial. The lesions will be observed for up to 12 months to determine presence or absence of keloid formation.

MRG-201 is designed to mimic the activity of microRNA-29 and decrease the expression of many proteins that are involved in fibrous scar formation. miRagen believes the results from its Phase 1 clinical trial of MRG-201 in induced cutaneous fibrosis, which demonstrated the ability of the product candidate to reduce fibrogenesis in humans after skin trauma when compared to untreated lesions, may provide support for the therapeutic approach in other pathological fibrotic conditions.

About miRagen Therapeutics, Inc.

miRagen Therapeutics, Inc. is a clinical-stage biopharmaceutical company discovering and developing proprietary RNA-targeted therapies with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. miRagen has three clinical stage product candidates, cobomarsen (MRG-106), MRG-201, and MRG-110. miRagen’s clinical product candidate for the treatment of certain cancers, cobomarsen, is an inhibitor of microRNA-155, which is found at abnormally high levels in malignant cells of several blood cancers, as well as certain cells involved in inflammation. miRagen’s clinical product candidate for the treatment of pathological fibrosis, MRG-201, is a replacement for microRNA-29, which is found at abnormally low levels in a number of pathological fibrotic conditions, including cutaneous, cardiac, renal, hepatic, pulmonary and ocular fibrosis, as well as systemic sclerosis. MRG-110, an inhibitor of microRNA-92, is being developed under a license and collaboration agreement with Servier for the treatment of heart failure and other ischemic disease. In addition to these programs, miRagen is developing a pipeline of preclinical product candidates. The goal of miRagen’s translational medicine strategy is to progress rapidly to first-in-human studies once it has established the pharmacokinetics, pharmacodynamic, safety and manufacturability of the product candidate in preclinical studies. For more information, please visit www.miragen.com.

SOURCE: miRagen Therapeutics

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