Radius Initiates Phase 2a Clinical Trial of RAD1901 in Menopausal Hot Flashes
--Study will evaluate proof of concept for company's first-in-class SERM designed to relieve vasomotor symptoms without side effects associated with hormone therapy--
"The initiation of this proof-of-concept trial is a significant milestone for Radius," said
"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
Clinical Trial Details
The Phase 2a clinical trial, which is being conducted at approximately six sites in
RAD1901 is a novel selective estrogen receptor modulator (SERM) under development at Radius as a new class of menopausal therapy. SERMs are small molecules that bind to and selectively modulate estrogen receptors. These molecules have the ability to stimulate or block estrogen's activity in different types of tissue, functioning as estrogen receptor agonists in some tissues and as estrogen receptor antagonists in others. Currently available SERMS are approved for the treatment and prevention of breast cancer and osteoporosis but tend to respectively increase the frequency and severity of hot flashes. In preclinical studies, Radius demonstrated RAD1901's potential to reduce vasomotor symptoms, along with a simultaneous bone-protective effect, without stimulating breast or uterine tissues. RAD1901 is distinctive from other SERMs in its unique biological profile, combined with its significant ability to penetrate the blood-brain barrier, which enables RAD1901 to function as an estrogen agonist within the central nervous system and thereby relieve hot flashes. RAD1901 was discovered by Eisai Co., Ltd. and licensed by Radius (excluding
About Vasomotor Symptoms (Hot Flashes)
Hot flashes are a common symptom during menopause, experienced by more than 75% of women during the menopause transition for a median duration of four years. These symptoms can disrupt sleep and interfere with quality of life. An estimated 6,000 U.S. women reach menopause every day (more than two million per year) with a total population of 50 million postmenopausal women. In addition, most women receiving systemic therapy for breast cancer suffer hot flashes, often with more severe or prolonged symptoms. Treatment with estrogen or hormone replacement therapy (ERT or HRT) is the standard of care for many women suffering hot flashes, but due to concerns about potentially serious risks and contraindications, including increased risk of developing heart disease, breast cancer, stroke, and dementia, there is a significant need for new therapeutic options.
About Radius (www.radiuspharm.com)
Radius is a leading company in the discovery and development of a new generation of drug therapies for osteoporosis and women's health. Radius has raised
Contact: Nick Harvey Chief Financial Officer (617) 551-4704
SOURCE Radius Health
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