FIBREX' MI drug sees good PK/safety profile

FIBREX Medical, a development-stage biopharmaceutical company based in Vienna, Austria, says it has successfully completed the first human dosing trial with its lead drug candidate FX06, which is being developed for the prevention of reperfusion injury after acute myocradial infarction.

The clincial trial measured the pharmacokinetics and tolerability of the peptide drug in healthy volunteers and, according to the firm, confirmed the "excellent" safety profile observed in animal studies. The firm says that a Phase II, 140-patient proof-of-concept trial with the agent is planned and will start enrollment in the second quarter of the year with topline results expected in May 2007.