FM-VP4 for the treatment of hyperlipidemia
April 2, 2004 by admin · Leave a Comment
On April 5, 2004 Forbes Medi-Tech Inc. announced preliminary results of its Phase II clinical trial of FM-VP4 for the treatment of hyperlipidemia. The company reported that statistical significance was achieved at the trial’s primary endpoint of lowering low density lipoprotein (LDL) cholesterol. An 11% reduction in LDL cholesterol, as compared to placebo, was reported with 33% of subjects taking the 400 mg per day dosage achieving a greater than 15% reduction. According to Forbes, FM-VP4 demonstrated an excellent safety profile with no difference between dosing and placebo groups.
FM-VP4 is a member of a new class of cholesterol lowering drugs, described as water and lipid soluble cholesterol absorption inhibitors or ‘phytostanol analogues’. The company has indicated that they plan to pursue this as an adjunctive therapy to statins in the treatment of hyperlipidemia and noted that the potential market for combination therapies in the treatment of high cholesterol may reach $4.7 billion dollars by 2011.
According to the American Heart Association, in excess of 100 million Americans presently have total blood cholesterol levels above 200 mg/dl. In addition, fewer than 50% of patients who would benefit from cholesterol lowering treatments are actually receiving them.
Although currently classified as a Moderate Impact Technology, FM-VP4, or any other adjunctive therapy (i.e. in addition to standard statin therapy) for the management of hyperlipidemia could potentially fulfill the Biohorizon criteria for a High Impact Health Technology. If approved, FM-VP4 could become standard therapy for patients not adequately controlled on statins alone. In this case, the addition of FM-VP4 to the standard statin therapeutic regimen would significantly increase the cost of treatment on a per patient basis. However, FM-VP4 has yet to enter pivotal Phase III trials. Due to the considerable time and uncertainty associated with this process, Biohorizon does not recommend assessment activities at this time.
Technology Details
Target Disease / Indication
Hyperlipidemia
Technology Classification
Drug
Body System
Cardiovascular System
Program Area
Medicine/Cardiology
Regulatory Status
Phase II
BioHorizon Impact Score
62/100 – Moderate
