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miRagen moves MRG-110 ahead
BOULDER, Colo.—miRagen Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, has announced today the initiation of a Phase 1 clinical trial of MRG-110 (S95010) by Servier. MRG-110 is a locked nucleic acid modified oligonucleotide inhibitor of microRNA-92.
According to miRagen’s website, “miRagen’s MRG-110 program targets miR-92a, a microRNA linked to the regulation of blood vessel growth. Increasing blood vessel growth is an attractive revascularization approach for the treatment for chronic ischemic disorders. AntimiR-92a offers a potential therapeutic to accelerate the healing process.”
In preclinical models, MRG-110 appeared to accelerate the formation of new blood vessels, which resulted in improved vascularization and improved functional outcomes. MRG-110 is the third product candidate from miRagen to enter human clinical trials. In this clinical trial, MRG-110 will be evaluated for safety and tolerability in a systemic dosing protocol that is intended to support potential further clinical trials that may lead to regulatory approval for the potential treatment of heart failure.
miRagen recently filed an investigational new drug application, or IND, for this study, which it expects to initiate in the first half of this year. In the clinical trial, miRagen plans to also examine several exploratory endpoints that are intended to provide mechanistic proof of concept and biomarker validation to support a global development plan that may include use in patients with high risk for complications after surgical incisions or chronic wounds.
“This clinical development milestone is an important step in our long-standing collaboration with Servier. The aspiration of our collaboration is to address cardiovascular and other diseases that have been difficult to treat with traditional therapeutic approaches,” said miRagen President and CEO William S. Marshall, Ph.D. “Cardiovascular disease is the leading cause of death worldwide, and over a third of the adult U.S. population suffers from at least one form of the disease. We look forward to the next step of development of MRG-110 which should guide how this product candidate may potentially be used as an innovative therapy for patients in need.”
The Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of MRG-110; and to potentially establish the recommended Phase 2 clinical trial dose for the treatment of patients with heart failure. The Phase 1 clinical trial is planned to enroll 49 male subjects, aged 18 to 45. In addition, the Phase 1 clinical trial results will be analyzed for biomarkers that may provide mechanistic proof of concept and support further potential clinical trials of MRG-110 in the treatment of cardiovascular disease and certain other conditions where vascular flow is compromised.
“This Phase 1 trial may allow miRagen and Servier to establish the recommended Phase 2 clinical trial dose for the treatment of patients with heart failure. The Phase 1 clinical trial results will also be analyzed for biomarkers that may provide mechanistic proof of concept and support further potential clinical trials of MRG-110 in the treatment of cardiovascular disease and certain other conditions where vascular flow is compromised,” says an earlier miRagen press release.
“miRagen [also] plans to initiate a separate Phase 1 trial assessing the safety and tolerability of MRG-110 after intradermal administration in healthy volunteers. The intradermal administration clinical trial is intended to support additional clinical studies necessary to achieve regulatory approval for the use of MRG-110 in other diseases, including dermatological applications, where increased vascularity may result in better healing and improved outcomes.”
In 2011, miRagen entered into a License and Collaboration Agreement with Servier for the research, development, and commercialization of RNA-targeting therapeutics in cardiovascular disease. Under the agreement, Servier has an exclusive license to research, develop, and commercialize MRG-110 outside the United States and Japan. Servier also has the right to name one additional target to the collaboration through September 2019. Servier’s rights are limited to therapeutics in the field of cardiovascular disease and in their territory, which is worldwide except for the United States and Japan.
miRagen retains all other rights including commercialization of therapeutics developed under the collaboration. Servier is responsible for funding certain costs of research and development under the collaboration. miRagen is also eligible to receive research and development milestone payments, commercial milestone payments, and royalties on the sale of the products developed under the collaboration, if any. Under the terms of the collaboration, Servier will pay miRagen a €3.0 million milestone for the dosing of the first patient in the Phase 1 trial.