MIRAGEN THERAPEUTICS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
Continued advancements of three clinical stage microRNA-targeted product candidates currently being evaluated for multiple potential indications in four clinical trials
Global Phase 2 SOLAR clinical trial of cobomarsen in CTCL expected to be initiated in the fourth quarter of 2018
$70.5 million in cash, cash equivalents, and short-term investments as of September 30, 2018
Conference call and webcast today at 4:30 p.m. ET
BOULDER, CO, November 7, 2018 - miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today reported third quarter 2018 financial results and provided a corporate update.
“We had a productive quarter in which we advanced preparations to launch our global Phase 2 SOLAR trial of cobomarsen in CTCL. We expect the trial to begin dosing patients in the fourth quarter of 2018,” said William S. Marshall, Ph.D., President and Chief Executive Officer of miRagen Therapeutics. “During the quarter, we announced our collaboration with The Leukemia and Lymphoma Society (LLS) to help support the SOLAR trial, including LLS providing up to $5.0 million in financial support.”
“We continue to make progress across our microRNA platform and expect to report data from multiple trials in 2019, including the Phase 1 cobomarsen trial in adult T-cell leukemia / lymphoma (ATLL); the Phase 2 proof of mechanism trial of remlarsen in keloids; and the ongoing clinical development of MRG-110 for cardiac and vascular indications in collaboration with Servier. With the needs of patients in mind, we are excited to advance three clinical stage product candidates and provide further evidence supporting the potential of microRNA-based therapeutics as an important new class of targeted therapies.”
miRagen expects its global Phase 2 SOLAR trial for cobomarsen to begin dosing patients diagnosed with cutaneous T-cell lymphoma (CTCL) during the fourth quarter of 2018. The SOLAR trial will evaluate the safety and efficacy of cobomarsen given by intravenous infusion in an active control comparison trial versus ZOLINZA (vorinostat). Approximately 65 patients per treatment group are expected to enroll in the trial. The primary endpoint of the SOLAR trial is the rate of an objective response, 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, maintained for at least four consecutive months. Progression-free survival will be 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, miRagen believes the results from this clinical trial could allow the Company to apply for accelerated approval in the United States. We expect to report data from this clinical trial in the second half of 2020.
In previously announced Phase 1 trial data, cobomarsen appeared to demonstrate durable responses measured by improvement in total skin tumor burden scoring and quality of life improvement in patients with the mycosis fungoides form of CTCL. Cobomarsen also appeared to be generally well tolerated at all dose levels evaluated. miRagen plans to present complete data from this Phase 1 trial at the 2018 American Society of Hematology (ASH) Annual Meeting in December. The data will include efficacy, safety and tolerability observations from long-term dosing of cobomarsen via various routes of administration in 43 patients who have been enrolled in the trial for up to 22 months.
miRagen is also evaluating cobomarsen in ATLL, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia, for which it has reported preliminary clinical responses in ATLL from its ongoing Phase 1 trial. The Company anticipates announcing additional ATLL data from this clinical trial in the first half of 2019.
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Wednesday, November 7, 2018 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.