Business
miRagen Announces Internal Review of Preliminary Topline Data for the Phase 2 SOLAR Clinical Trial of Cobomarsen in Patients with Cutaneous T-Cell Lymphoma (CTCL)
miRagen decides to discontinue further internal development of cobomarsen BOULDER, Colo., Oct. 05, 2020 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc.
About this update from Viridian Therapeutics, Inc.
[{"type":"text","content":"miRagen decides to discontinue further internal development of cobomarsen\nBOULDER, Colo., Oct. 05, 2020 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, announced today that it has conducted an internal review of preliminary topline data from its Phase 2 SOLAR clinical trial of cobomarsen in patients with Cutaneous T-Cell Lymphoma (CTCL). Based on investigator assessments, these preliminary data in 37 patients suggest that cobomarsen lacks a compelling result for the study's primary endpoint, objective skin response of at least four months duration (ORR4) relative to the vorinostat control arm. Progression free survival (PFS), a secondary endpoint for the study, indicates a treatment effect in favor of cobomarsen. In addition, cobomarsen was well tolerated, with no patient discontinuations due to cobomarsen-related adverse events.\n The SOLAR study was designed to evaluate the safety and efficacy of cobomarsen given by intravenous infusion in an active control comparison trial for patients with the mycosis fungoides subtype of CTCL. In December 2019, miRagen announced it would halt enrollment in the SOLAR trial well short of the intended 126 CTCL patients in order to reduce the time and resource expenditure to evaluate the drug’s potential. The downsized SOLAR study is not statistically powered for superiority or equivalence. “We have completed this preliminary evaluation and will continue to analyze the final topline data and other secondary SOLAR data as we seek a partner for cobomarsen,” stated Ms. Lee Rauch, President and Chief Executive Officer. “Our research and development strategy remains focused on the advancement of our lead program MRG-229 for Idiopathic Pulmonary Fibrosis (IPF).” In addition, as recently announced, the Board of Directors continues to evaluate strategic alternatives for the Company. Potential strategic alternatives may include, but are not limited to, an acquisition, merger, business combination, in-licensing, or other strategic transactions. There can be no assurance that this process will result in any such transaction. miRagen has not set a timetable for completion of this process and does not intend to comment further on this process unless or until the Board of Directors h...