MRG-201 has been generally well-tolerated in volunteers
Findings support further investigation of MRG-201 as a novel therapeutic for fibrotic diseases
BOULDER, CO –April 27, 2017 – Miragen Therapeutics, Inc. (Nasdaq: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of microRNA-targeted therapies, today presented at the Society for Investigative Dermatology (SID) 76th Annual Meeting. miRagen discussed previously announced interim results from its ongoing Phase 1 clinical trial of MRG-201. MRG-201 is designed to mimic the activity of microRNA-29, which has been shown to decrease the expression of certain genes that are involved in scar formation.
MRG-201 is being evaluated in a single center, Phase 1, double-blind, placebo-controlled, single and multiple-dose escalation clinical trial. As of mid-March 2017, 54 volunteers had participated in the clinical trial. Expression of microRNA-29 and its pharmacodynamic biomarkers was assessed in untreated skin incisions and following single or multiple administrations of MRG-201 at the site of a skin incision. Data from the trial include the following:
- Where volunteers’ skin was incised without receiving MRG-201, microRNA-29 expression was decreased and direct target genes were upregulated as compared to unincised skin;
- Where volunteers received intradermal injections of MRG-201, pharmacokinetic analysis of the volunteers’ plasma revealed that very little drug (less than 150 ng/mL) was generally detectable in the volunteers’ blood;
- MRG-201 was generally well tolerated at all dose levels evaluated;
- Pharmacodynamic activity was seen after MRG-201 treatment: single and multiple doses of MRG-201 were generally accompanied by reduced expression of certain genes associated with fibrosis as compared to a placebo injected incision in the same volunteer; and
- Multiple administrations of MRG-201 were generally accompanied by reduced fibroplasia, a marker of scar formation, as assessed by histopathology (p<0.01)
“Previous studies by miRagen researchers have suggested that microRNA-29 may be an attractive therapeutic target for the treatment of cutaneous and other forms of pathological fibrosis,” said Paul Rubin, M.D., miRagen’s Executive Vice President of Research and Development. “We are pleased that our interim Phase 1 trial results demonstrate that MRG-201 target engagement may correlate with the impact on fibroplasia and that the treatment was generally well tolerated in intact and incised skin.”
“We believe that the interim results from the MRG-201 Phase 1 clinical trial are encouraging, as we explore this initial application in scar formation. It is also an excellent example of how we apply our “foothold” clinical development strategy. We view the trial data and mechanistic evidence observed from our approach to treating fibrosis in the skin as supportive of our assertion that MRG-201 may have broader applications in other pathological fibrotic conditions,” said miRagen President and CEO William S. Marshall, Ph.D. “We believe these findings support further investigation of MRG-201 as a therapeutic to inhibit scar formation, and may also provide support for applications in additional indications.”
About Miragen Therapeutics, Inc.
Miragen Therapeutics, Inc. is a clinical-stage biopharmaceutical company discovering and developing proprietary RNA-targeted therapeutics with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. miRagen’s two lead product candidates, MRG-106 and MRG-201, are currently in Phase 1 clinical trials. miRagen’s clinical product candidate for the treatment of certain cancers, MRG-106, is an inhibitor of microRNA-155, which is found at abnormally high levels in several blood cancers. miRagen’s clinical product candidate for the treatment of pathological fibrosis, MRG-201, is a replacement for miR-29, which is found at abnormally low levels in a number of pathological fibrotic conditions, including cardiac, renal, hepatic, and pulmonary fibrosis, as well as systemic sclerosis. In addition to miRagen’s clinical programs, it is developing a pipeline of pre-clinical 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, pharmacodynamics and safety of the product candidate in pre-clinical studies. For more information, please visit www.miragentherapeutics.com.
For information on clinical trials please visit www.clinicaltrials.gov.
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