Radius Health initiates dosing in Phase IIa hot flashes trial

Radius Health, a developer of new drug therapies for osteoporosis and women’s health, has dosed the first patient in the company’s proof-of-concept Phase IIa study of RAD1901, an investigational selective estrogen receptor modulator undergoing clinical evaluation for treatment of vasomotor symptoms.

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 Phase IIa 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, luteinizing hormone, and lipid profile effect-will be collected.

Richard Lyttle, president and CEO of Radius, said: The initiation of this proof-of-concept trial is a significant milestone for Radius. A positive outcome of this Phase IIa 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.