Servier has commenced a Phase I clinical trial analysing the safety, tolerability and pharmacokinetics of MRG-110 (S95010) for the treatment of cardiovascular disease.
As part of the trial, MRG-110 will be examined in a systemic dosing protocol that aims to support potential further clinical trials that may lead to regulatory approval for the heart failure treatment.
The trial will enrol 49 male patients aged 18 to 45 years, and seeks to establish the recommended Phase II clinical trial dose for the treatment of patients with heart failure.
Findings will be evaluated for biomarkers that may provide mechanistic proof of concept, as well as support further clinical trials of MRG-110 to treat cardiovascular disease and other conditions where vascular flow is compromised.
The trial will be conducted under a license and collaboration agreement signed between Servier and miRagen Therapeutics in 2011 for the research, development, and commercialisation of RNA-targeting therapeutics in cardiovascular disease.
Under the deal miRagen has commercialisation rights for MRG-110 in the US and Japan, while Servier holds an exclusive license to research, develop, and commercialise MRG-110 in the rest of the world.
Servier will also make a €3m milestone payment to miRagen for the dosing of the first patient in the newly conducted trial.
MRG-110 is miRagen’s third product candidate to enter human clinical trials. It is developed to inhibit the activity of microRNA-92 and to be a regulator of new blood vessel creation.
miRagen Therapeutics president and CEO William Marshall said: “Cardiovascular disease is the leading cause of death worldwide, and over a third of the adult US 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.”
Later this year, miRagen intends to sponsor a separate Phase I clinical trial in the US to evaluate the local and systemic safety and tolerability of MRG-110 after intradermal injection.