Date: 2011-02-24
Type of information:
phase: 1
Announcement: completion of the study
Company: Trophos (France)
Product: TRO40303
Action mechanism: mitochondria pore modulator. The mechanism of action of TRO40303 involves prevention of stress-induced mitochondrial permeability transition, a target implicated in cardiac reperfusion injury. Studies reported by Trophos and colleagues recently in JPET (Schaller et al, http://www.ncbi.nlm.nih.gov/pubmed/20215409) show that TRO40303 binds directly to the cholesterol site of the mitochondrial outer membrane protein, TSPO, which is highly expressed in heart and is associated to the mitochondrial permeability transition pore, allowing rapid uptake of TRO40303 into cardiac tissue.
Disease: acute myocardial infarction
Therapeutic area: Cardiovascular diseases
Country: France
Trial
details: Trophos has successfully completed its phase 1 dose escalation study of TRO40303. The objective of the phase 1 study was to assess the safety, tolerability and pharmacokinetics of single escalating doses of TRO40303 as an intravenous infusion at different rates compared with placebo in 72 healthy volunteers. The results demonstrate that TRO40303 can be safely administered by the i.v. route in humans at doses expected to be pharmacologically active. Trophos plans to present the full results of this study at a major cardiology congress in the second half of 2011.
Latest news: The phase 2 proof-of concept trial of TRO40303 will be initiated in the second half of this year with Trophos’ consortium partners in the EU funded MitoCare project. It will be performed by a consortium of prominent European clinical investigators, all of whom have extensive prior experience conducting and collaborating in large multi-centre clinical trials in cardiac IRI. The principal investigator will be Professor Dan Atar from Oslo University Hospital, Norway. The study will be a placebo controlled, phase 2 proof-of-concept study in acute MI patients with large myocardial infarct undergoing percutaneous transluminal coronary angioplasty (PTCA also known as coronary or balloon angioplasty) during percutaneous coronary intervention (PCI). TRO40303 will be administered as a single iv infusion prior to the reperfusion by angioplasty.
