Date: 2017-04-27
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the Society for Investigative Dermatology (SID) 76th Annual Meeting
Company: Miragen Therapeutics (USA - Co)
Product: MRG-201
Action
mechanism: microRNA. MRG-201 is an anti-fibrotic miRNA whose expression is downregulated in multiple fibrotic indications including in cutaneous scars, keloids and burns. Its target genes include numerous collagens and other extracellular matrix molecules, suggesting that restoration of miR-29 expression in a skin wound or at the site of an excised scar could have a therapeutic benefit by reducing scarring and/or preventing scar regrowth.
Disease: pathological fibrosis
Therapeutic
area: Fibrotic diseases
Country: Canada
Trial
details: The primary objective of this study is to evaluate the safety and tolerability of MRG-201 in healthy volunteers.
MRG-201 will be tested in healthy volunteers by injection into intact skin or adjacent to a short skin incision. Volunteers may receive one or several doses of MRG-201, and will be monitored for local reactions in the skin, signs or symptoms of adverse effects on the body, and for the levels of MRG-201 in the blood over time. Skin biopsies will also be collected to study how cells in the skin respond when exposed to MRG-201. (NCT02603224)
Latest
news:
- • On April 27, 2017, Miragen Therapeutics presented at the Society for Investigative Dermatology (SID) 76th Annual Meeting. miRagen discussed 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).
- Miragen intends to further investigate MRG-201 as a therapeutic to inhibit scar formation.
- • On November 12, 2015, miRagen Therapeutics 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.
- 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.
Is
general: Yes
