Miragen Therapeutics said it will reduce the sample size of its mid-stage study of cancer drug candidate cobomarsen to about 30 patients from 126 patients and lay off some employees as part of a broader restructuring strategy.
The biotechnology company is evaluating cobomarsen as a treatment for patients with cutaneous T-cell lymphoma — a rare skin cancer — in a phase 2 trial called Solar.
Miragen plans to request a meeting with the U.S. Food and Drug Administration to explore an expedited development pathway for cobomarsen to treat adult T-cell leukemia/lymphoma. The request will be based on data from the phase 1 study of the drug that enrolled multiple types of cancer patients, including those with diffuse large B-cell lymphoma and chronic lymphocytic leukemia.
Along with other measures, Miragen said it will also reduce its workforce by 18 and that related severance and other costs over a seven-month period would come to about $700,000.
The changes to the Solar trial and employee cuts will ensure cash and cash equivalents are sufficient to fund Miragen's operations into the fourth quarter of 2020, the company said in a press release.
Miragen also laid off about 26 employees in August, mainly in research, as part of a cost restructuring plan.
The Boulder, Colo.-based biotech company said it will focus future research efforts primarily on developing experimental therapy MRG-229 as a treatment for idiopathic pulmonary fibrosis, a type of lung disease that results in scarring of the lungs.
The company may also seek a collaboration partner for the future development of another drug candidate remlarsen, being evaluated for safety, tolerability and activity in a phase 2 trial in patients with keloid scars — hard surfaces formed due to excessive growth of scar tissue that can be much larger than the original wound.