miRagen Therapeutics Inc. (NASDAQ:MGEN) has announced that it is carrying an internal review of initial topline data from the second phase SOLAR clinical study of cobomarsen in treating Cutaneous T-Cell Lymphoma patients.
SOLAR trial of cobaomarsen fails to meet the primary endpoint
Based on investigators’ assessments, the initial data from 37 patients suggests that cobomarsen didn’t show a compelling outcome for the primary endpoint of the study relative to the vorinostat control group. The primary endpoint was objective skin response after a four-month duration. On the other hand, progression-free survival (PFS) was the secondary endpoint of the trial, and cobomarsen showed treatment effect on subjects. Equally, cobomarsen was favourably tolerated without any reported incidences of treatment discontinuation because of adverse events.
The company designed the SOLAR study to evaluate the efficacy and safety of intravenously delivered cobomarsen in active control companion study patients having a CTCL form of mycosis fungiodes. In December last year, the company announced that it will suspend enrolment in the study short of the expected 126 patients with CTCL. This was meant to reduce the resources and time required to evaluate the potential of the drug. Most importantly, this downsized SOLAR trial has not been powered statistically by equivalence its superiority.
miRagen focusing on its lead MRG 229 program
Lee Rauch, the CEO, and president of the company said they have completed the study’s initial evaluation. The focus now is an analysis of the final topline results and additional SOLAR data as the company seeks a partner for cobomarsen. She added that the company’s research and development strategy remains focused on advancing its lead program MRG-229 for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Besides releasing the results, the company’s Board of Directors has continued evaluating strategic alternatives for miRagen. Some of the possible strategic options include but not limited to merger, an acquisition, in-licensing, business combination, and other strategic transactions. However, there is no assurance that the process could lead to any of the transactions.