MIRAGEN ANNOUNCES FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND PROVIDES 2019 OUTLOOK
•Cobomarsen tested in clinical trials for three different types of blood cancers
•Multiple clinical sites open and actively recruiting in the global Phase 2 SOLAR clinical trial of cobomarsen in CTCL
•Data from four clinical trials of three product candidates expected to be released in 2019
•$62.5 million in cash, cash equivalents, and short-term investments as of December 31, 2018
•Management to host conference call today at 4:30 p.m. ET
BOULDER, CO, March 13, 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 and operating results for the fourth quarter and full-year ended December 31, 2018.
“We are encouraged by the advances our team has made in the development of microRNA targeted therapies in 2018 and pleased to begin 2019 with three clinical stage product candidates being evaluated in five clinical trials for the potential to treat patients who suffer from a variety of diseases with high unmet medical need.” said William S. Marshall, Ph.D., President and Chief Executive Officer of miRagen Therapeutics. “In addition to the release of encouraging clinical data for cobomarsen in cutaneous T-cell lymphoma (CTCL), we have also seen exciting preliminary clinical activity for cobomarsen in other blood cancers and have also advanced the development of remlarsen into a Phase 2 clinical trial in cutaneous fibrosis. Further, we are working closely in collaboration with Servier on the clinical development of MRG-110 for cardiovascular disease and other potential indications.”
“As we advance through 2019, we are intensely focused on the achievement of several important clinical milestones, including the enrollment of patients in our global Phase 2 SOLAR trial of cobomarsen in CTCL and releasing clinical data from four additional ongoing clinical trials throughout 2019.”
Recent Program Highlights and Outlook
In January 2019, miRagen announced updated durability data for the 300 mg intravenous infusion cohort of the Phase 1 cobomarsen clinical trial, which is the dose and route of administration being used in the SOLAR Phase 2 clinical trial, that showed four of eight patients (50%) achieved an objective response with greater than four months of durability (ORR4). In addition, the topline Phase 1 cobomarsen data 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 believes that data from the Phase 1 clinical trial provides clinical proof-of-concept for cobomarsen in patients with mycosis fungoides. The Company’s global Phase 2 SOLAR trial for cobomarsen in patients diagnosed with mycosis fungoides is in the startup phase with initial dosing expected during early 2019. The SOLAR trial is designed to evaluate the safety and efficacy of cobomarsen given 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, 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.
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Wednesday, March 13, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.