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news.Trophos, a French clinical stage pharmaceutical company that develops innovative neurological and cardiological therapeutics, has successfully completed the phase 1 dose escalation study of TRO40303, a novel mitochondria pore modulator.
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The success could help make TRO40303 the first treatment to reduce cardiac reperfusion injury which leads to morbidity and mortality myocardial infarction.
The study was aimed at assessing 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.
Results showed that TRO40303 could be safely administered by the iv route in humans at pharmacologically active doses.
Trophos CMO Jean-Louis Abitbol said the phase 1 results encourage the initiation of the phase 2 proof-of concept trial of TRO40303 in the second half of 2011 with the company’s consortium partners in the EU which will be funded MitoCare project.
The phase 2 proof-of-concept study will have Oslo University Hospital professor Dan Atar as the principal investigator.
It will be placebo-controlled, and will have acute MI patients with large myocardial infarct undergo percutaneous transluminal coronary angioplasty during percutaneous coronary intervention.
TRO40303 will be administered as a single iv infusion prior to the reperfusion by angioplasty.