Date: 2013-08-07
Type of information:
phase: 1
Announcement: enrollment of the first volunteer
Company: Congenia (Italy)
Product: GNX-5086
Action
mechanism: Inhibition of the mPTP is proposed as a cardioprotective strategy for the limitation of infarct size in patients undergoing PCI. GNX-5086 is a potent mPTP inhibitor able to increase the capacity of isolated mitochondria to retain calcium and thus protect the mitochondria from calcium overload in stress situations. In vivo studies using a rabbit model of acute myocardial infarction clearly demonstrate the effectiveness of GNX-5086 in attenuating RI and reducing infarct size when administered just prior to heart reperfusion.
GNX-5086 is being developed to treat cardiac reperfusion injury that contributes significantly to the morbidity and mortality subsequent to myocardial infarction.
Disease: myocardial infarction
Therapeutic area: Cardiovascular diseases
Country: The Netherlands
Trial
details: The randomized, double-blind, placebo-controlled Phase 1 study in healthy subjects is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of GNX-5086. The study is expected to enroll 33 healthy volunteers.
Latest
news: * On August 27th 2013, Congenia, a clinical stage biopharmaceutical company focused on developing inhibitors of the mitochondrial permeability transition pore (mPTP), has announced the initiation of healthy volunteer enrollment in a Phase 1 clinical trial evaluating the safety and tolerability of GNX-5086. GNX-5086 is being developed for intravenous administration to infarcted patients just prior to percutaneous coronary intervention (PCI). The clinical trial application (CTA) to initiate the Phase 1 study of GNX-5086 was filed on July 4th 2013 in the Netherlands and received approval by the local regulatory authorities on July 24th.GNX-5086 is Congenia’s most advanced compound and was selected as lead compound through a longstanding preclinical collaboration with the Drug Discovery Program of the European Institute of Oncology (DDP-IEO).
