QuatRx Pharmaceuticals Initiates Phase I Trial For Treatment To Reduce Both LDL Cholesterol And Lipoprotein (A)

Main Category: Cholesterol
Also Included In: Cardiovascular / Cardiology;  Clinical Trials / Drug Trials
Article Date: 29 Sep 2006 - 0:00 PDT

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QuatRx Pharmaceuticals, a privately held biopharmaceutical company focused on research and development of therapeutic compounds for the treatment of major endocrine, metabolic and cardiovascular diseases, today announced that it has initiated a Phase I clinical study of QRX-431, a novel compound in development for the treatment of elevated cholesterol levels and obesity.

In pre-clinical primate studies, QRX-431, a selective thyroid beta agonist, lowered LDL, lipoprotein (a) and weight without significantly increasing heart rate. High levels of low-density lipoproteins (LDL) have been shown to be a major cause of coronary heart disease, a condition affecting more than 13 million Americans. Elevated lipoprotein (a) [Lp(a)] has been linked to an increased risk of stroke and coronary heart disease.

"We are extremely encouraged by the preclinical results for QRX-431. We feel this new drug candidate offers great promise as a therapy to help the millions of people with elevated lipid levels and obesity who may be at risk for stroke and coronary heart disease," said Robert L. Zerbe, M.D., chief executive officer and president of QuatRx.

Preclinical Study Results

In preclinical primate studies, QRX-431 significantly reduced LDL cholesterol and Lp(a). To date, there are no approved therapies for the treatment of elevated Lp(a) levels. Study results also suggest that QRX-431 activates reverse cholesterol transport, a protective mechanism involving transport of cholesterol from the arteries to the liver. QRX-431 may also act to induce weight loss. QRX-431 demonstrated a weight reduction in seven days in a primate study and did not significantly affect heart rate.

LDL Cholesterol, Cardiovascular Disease and Current Treatments

Collectively, more than 71 million Americans have some form of cardiovascular disease, according to the American Heart Association. Cardiovascular disease is the number one killer in the United States, claiming more lives than cancer, chronic lower respiratory diseases, accidents, and diabetes combined. Statins are commonly used to lower LDL cholesterol and reduce the risk of cardiovascular disease. Though effective for many people with high LDL cholesterol, statins have no effect on Lp(a), can cause many side effects and many people cannot tolerate the higher doses needed to achieve target LDL levels. Thyroid hormone has been shown to lower LDL levels and Lp(a), but unlike QRX-431, thyroid hormone also stimulates the thyroid alpha receptor, which produces increases in heart rate. For this reason, thyroid hormone has not been considered a viable therapy for lowering cholesterol or weight.

About QuatRx

QuatRx Pharmaceuticals Company is focused on discovering, licensing, developing and commercializing compounds in the endocrine, metabolic and cardiovascular therapeutic areas. In addition to QRX-431, QuatRx currently has three product candidates in clinical development. QuatRx's two lead compounds target hormone deficiencies that result from aging in women and men. Ophena(TM) is in Phase III development initially for the treatment of vaginal atrophy, a common problem associated with estrogen deficiency in post- menopausal women. Fispemifene, a treatment for testosterone deficiency, is in Phase II clinical testing. QuatRx is also developing Asord(TM), a topical product candidate for the treatment of psoriasis, which has completed a Phase IIb clinical trial.

QuatRx Pharmaceuticals Company
http://www.quatrx.com