The design of the upcoming US phase II trial incorporates the knowledge gathered from both preclinical studies and a European proof of concept trial in humans. The planned US phase II trial includes enhancements to the dosing regime, length of trial and patient population with an end target of 15% reduction in LDL-cholesterol.
“The IND represents the culmination of clinical and preclinical study results and our commitment to initiating an important human trial for FM-VP4,” said Charles Butt, president and CEO of Forbes Medi-Tech. “We are aggressively pursuing the further development of this drug to address the world’s largest pharmaceutical market, which is estimated to grow from $23 billion in 2005 to $40 billion by 2011.”
FM-VP4 is a cholesterol absorption inhibitor, a new class in cholesterol lowering drugs. The drug has demonstrated significant cholesterol-lowering and anti-atherosclerotic properties in preclinical studies.