Quatrx Pharmaceuticals Reports Positive Results From A Phase 2 Trial Of Fispemifene

Trial results indicate that the novel, oral, selective estrogen receptor antagonist significantly increases testosterone in androgen-deficient men by up to 78% in four weeks.

ANN ARBOR, MI, USA | Jan 08, 2007 |
QuatRx Pharmaceuticals today announced positive results from its Phase 2 clinical study of fispemifene in men with low testosterone levels. Fispemifene is a new, selective estrogen receptor antagonist that is being developed as an oral treatment for testosterone deficiency and associated disorders in men. Symptoms of low testosterone include sexual dysfunction, muscle wasting, reduced bone density, lowered energy levels and glucose intolerance. Unlike current exogenous testosterone treatments, fispemifene is administered orally once daily and is designed to use the body’s natural mechanism to increase and maintain testosterone levels within the body’s normal physiologic range.

In the randomized, double-blind, placebo-controlled study conducted at 23 sites in the United States, 77 men with secondary hypogonadism were evaluated after four weeks of treatment. Patient groups treated with 100, 200 and 300 mg doses of fispemifene showed a 60%, 60% and 78% increase in testosterone levels, respectively, compared to baseline, while patients treated with placebo showed a 14% increase in testosterone levels (p<0.05, p<0.01, p<0.001 (fispemifene vs. placebo), respectively). Actual increases in total testosterone ranged from 28.3 ng/dL for placebo to 196.5 ng/dL for 300 mg fispemifene. In all dose-groups the mean testosterone level increased into the normal range of 300 ng/dl to 900 ng/dl. All primary endpoints defined by the study protocol were met and no safety issues were observed.

“Testosterone deficiency is a significant health issue affecting millions of men,” remarked Robert L. Zerbe, M.D., chief executive officer and president of QuatRx. “Because current therapies usually involve injections or topical application of testosterone, we believe they have not meaningfully addressed the market need. With fispemifene, a novel oral compound, we have the potential to offer patients an alternative to testosterone replacement therapy.”

Androgen Deficiency and Treatment Options

Androgen deficiency, or low testosterone, is associated with aging (andropause) and with a wide range of disorders including HIV, obesity, chronic obstructive pulmonary disease, diabetes and other conditions. It is a common condition affecting millions of men and is associated with loss of sexual drive, muscle wasting and weakness, bone loss and frailty. Current treatment options typically include injectable or topical formulations of exogenous testosterone.

About QuatRx

QuatRx Pharmaceuticals Company is a privately-held biopharmaceutical company focused on the discovery, development and commercialization of compounds to treat endocrine, metabolic and cardiovascular disorders. In addition to fispemifene, QuatRx has three other product candidates in active clinical development and two in preclinical development. Ophena™, being studied in a large Phase 3 trial, is a potential estrogen-free therapy for post-menopausal vaginal syndrome, a common problem that results from thinning of vaginal tissues associated with estrogen deficiency of menopause. QRX-431, a novel, selective thyroid receptor beta antagonist is in early clinical studies as a potential treatment for elevated cholesterol levels. Asord™, a topical product candidate for the treatment of mild to moderate psoriasis, has completed a Phase IIb clinical trial. And, QuatRx’s two preclinical programs are proprietary small molecule drugs designed to address common endocrine disorders in women.

SOURCE: QuatRx Pharmaceuticals

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