Tekmira wins FDA clearance to initiate Phase I study of cholesterol drug

Canadian biopharmaceutical company Tekmira Pharmaceuticals has reported that its investigational new drug or IND application for ApoB SNALP has received clearance from the FDA allowing it to begin enrolling patients in a Phase I human clinical trial.

ApoB SNALP, Tekmira’s lead RNAi therapeutic product candidate, is being developed as a treatment for patients with elevated low-density lipoprotein (LDL) cholesterol, or ‘bad’ cholesterol. ApoB SNALP is designed to reduce the production of apolipoprotein B (ApoB), a protein produced in the liver that plays a central role in cholesterol metabolism.

The Phase I clinical trial will evaluate the safety, tolerability and pharmacokinetics of escalating single doses of ApoB SNALP in approximately 30 patients with elevated LDL cholesterol. The trial is also designed to provide preliminary data on the ability of ApoB SNALP to lower serum LDL cholesterol levels. Phase I data is expected to be available in late 2009 or early 2010.

According to Tekmira, the therapeutic activity of ApoB SNALP has been demonstrated in preclinical models of high cholesterol. Rodents fed a high fat diet demonstrate a 50-100% increase in total cholesterol in the blood. A single ApoB SNALP treatment can overcome such diet-induced high cholesterol, returning blood cholesterol levels to normal. The suppressive effects of a single ApoB SNALP dose lasts for several weeks in preclinical models of high cholesterol.

Mark Murray, Tekmira’s president and CEO, said: The successful FDA review of our ApoB SNALP IND is a testament to the scientific quality of our IND submission. We remain on track to achieve our milestone of initiating a Phase I clinical trial before mid-year in patients with high cholesterol.