MIRAGEN ANNOUNCES FIRST QUARTER 2019 FINANCIAL RESULTS
AND PROVIDES CORPORATE UPDATE
•Initiated patient dosing in the SOLAR Phase 2 trial for cobomarsen
•Released updated clinical data from the Phase 1 trial of cobomarsen in ATLL patients
•Released data from preclinical studies showing the antifibrotic effects of remlarsen in corneal injury
•$51.0 million in cash, cash equivalents, and short-term investments as of March 31, 2019
•Management to host conference call today at 4:30 p.m. ET
BOULDER, CO, May 8, 2019 - miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company developing proprietary RNA-targeted therapies with a specific focus on microRNAs, today reported financial results for the first quarter ended March 31, 2019 and provided a corporate update.
“Execution on our strategy by the miRagen team over the past few quarters has allowed us to make important advances in the development of cobomarsen, remlarsen, and MRG-110 in 2019, including initial dosing in the SOLAR Phase 2 trial of cobomarsen and the recent release of new data from our Phase 1 trial of cobomarsen in adult T-cell leukemia/lymphoma (ATLL) patients,” said William S. Marshall, Ph.D., President and Chief Executive Officer of miRagen Therapeutics.
“In addition to cobomarsen, we continue to make progress advancing remlarsen and MRG-110. We look forward to releasing additional data from three clinical trials during the remainder of 2019, including our Phase 2 clinical trial of remlarsen in keloid scarring and two Phase 1 trials for MRG-110,” continued Dr. Marshall.
Recent Program Highlights
In April 2019, the first mycosis fungoides patients were dosed in the SOLAR Phase 2 trial. The SOLAR trial is designed to evaluate the safety and efficacy of cobomarsen given in 300 mg doses by intravenous infusion in an active control comparison trial versus vorinostat. miRagen has opened a number of clinical sites in the trial and is planning to initiate activities at up to sixty clinical sites in eleven countries worldwide. The primary endpoint of the SOLAR trial is the rate of an objective response that is durable for four months, defined as 50% or greater improvement in the severity of a patient’s skin disease over the entire body with no evidence of disease progression in the blood, lymph nodes, or viscera. Progression-free survival is a secondary endpoint, and miRagen plans to use patient-reported outcomes as additional endpoints to monitor quality of life improvements. Based on discussions with the U.S. Food and Drug Administration (FDA), miRagen believes that primary endpoint data from this clinical trial could allow miRagen to apply for accelerated approval in the United States. The Company expects to report primary endpoint data from this clinical trial in the second half of 2020.
miRagen is also evaluating cobomarsen in certain expansion indications where the disease process appears to be correlated with an increase in miR-155 levels, the target of cobomarsen. The Company recently announced new data from the ATLL cohort of its Phase 1 clinical trial of cobomarsen in an oral presentation at the 19th International Congress HTLV 2019. In the updated data from the trial, five patients with aggressive ATLL subtype in partial remission have been treated with cobomarsen for up to 16 months. Four of the five patients remained stable for up to 16 months and continued dosing. Biological activity of cobomarsen in these patients is indicated by a significant decrease in biomarkers of cell proliferation (e.g., Ki67) and activation (e.g., HLD-R and CD69) in all patients, supporting the observed clinical stabilization. Cobomarsen has been well tolerated over prolonged treatment, with no deaths, dose limiting toxicities, related serious adverse events, related Grade 3 or Grade 4 adverse events, hematological events or discontinuation from trial due to related adverse events.
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Wednesday, May 8, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.