miRagen to Present Results of Early Study on Inhaled Anti-fibrotic Therapy for IPF at ERS Congress

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by Magdalena Kegel |

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miRagen Therapeutics will release preclinical data supporting an inhaled version of its investigational treatment MRG-201 for idiopathic pulmonary fibrosis (IPF) at the European Respiratory Society (ERS) International Congress that opens Saturday.

At the meeting, which runs Sept. 9–13 in Milan, Italy, miRagen will present the poster, “Feasibility, distribution, and efficacy of an inhaled oligonucleotide mimic of miR-29 for pulmonary fibrosis induced by bleomycin in rats.”

The company also recently completed a Phase 1 clinical trial (NCT02603224) evaluating MRG-201 injected into the skin of more than 50 healthy volunteers. To date, only early data on this study has been released.

MRG-201 is a compound developed to mimic the actions of  microRNA-29 — a factor that researchers think is involved in fibrosis formation. IPF patients have abnormally low levels of the molecule, which acts by controlling the activity of genes.

miRagen’s earlier studies suggest that MRG-201 might control the production of the so-called extracellular matrix, composed of collagen and other molecules that are involved in fibrosis build-up.

The Phase 1 trial tested the product by making small cuts into the volunteers’ skin. Researchers then compared untreated wounds to those injected with MRG-201 or a placebo by analyzing tissue samples.

Interim results, released by the company, showed lower than usual levels of microRNA-29 and upregulated target genes during the scar formation process in untreated participants. Those who received MRG-201 injections into cut skin showed reduced activity of genes involved in fibrotic processes and scar formation, compared to those with cuts injected with a placebo.

Injections were generally well-tolerated, and researchers found very little of the drug in participants’ blood.

“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,” William S. Marshall, miRagen’s president and CEO, said in a press release at the time the results were announced.

“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,” he added.

miRagen also previously reported preclinical results showing that MRG-201 reversed lung fibrosis in mice.