Radius Health has announced today that the first patient has been dosed in the company's proof-of-concept Phase 2a study of RAD1901, an investigational selective estrogen receptor modulator (SERM) undergoing clinical evaluation for treatment of vasomotor symptoms (menopausal hot flashes).
The clinical trial is designed to evaluate the ability of RAD1901 to relieve menopausal hot flashes without the administration of estrogen. RAD1901 has demonstrated positive effects in preclinical models of vasomotor symptoms and a favorable safety profile in Phase I human clinical studies.
"The initiation of this proof-of-concept trial is a significant milestone for Radius," said C. Richard Lyttle, PhD, President and CEO of Radius. "A positive outcome of this Phase 2a clinical trial would further position RAD1901 as a next-generation SERM that provides an alternative to estrogen in alleviating menopausal hot flashes, without the side effects associated with hormone therapy. We look forward to reporting the results of this trial later in 2009."
"RAD1901 represents an ideal candidate for the potential treatment of postmenopausal vasomotor symptoms, given its unique clinical profile demonstrated in preclinical and Phase I studies--estrogen-agonist effects on the central nervous system while protecting against breast and uterine tissue stimulation," said Louis O'Dea, MD, Chief Medical Officer of Radius. "This Phase 2 trial will provide us with critical insight into the dose-response relationship between increasing doses of RAD1901 and efficacy in the treatment of hot flashes."
Clinical Trial Details
The Phase 2a clinical trial, which is being conducted at approximately six sites in Argentina, is a double-blind, placebo-controlled, dose-ranging study in 100 otherwise healthy menopausal women experiencing recurrent moderate-to-severe hot flashes who will be randomized to receive one of four doses of RAD1901 and placebo. The duration of treatment after screening and baseline will be 28 days. The primary endpoint of the study is the frequency and severity of hot flashes relative to baseline. In addition, data on changes in pharmacodynamic markers of estrogen effect--follicle-stimulating hormone (FSH), luteinizing hormone (LH), and lipid profile effect--will be collected.
About RAD1901