Radius Health Initiates Phase III Trial of Osteoporosis Injection Drug for Males

Radius Health, Inc. (Nasdaq:RDUS) announced Friday (3/30/2018) that the company has initiated the Phase 3 ATOM (Abaloparatide Treatment for Osteoporosis in Males) study of abaloparatide injection (Tymlos) for the treatment of osteoporosis in men. 

"Approximately 20 percent of men over the age of 50 years will sustain an osteoporotic-related fracture in their lifetime attributed to multiple risk factors. If successful, this study will serve as the basis of a supplemental New Drug Application (sNDA) seeking to expand the use of abaloparatide to treat men with osteoporosis at high risk for fracture,” said Gary Hattersley, PhD, Chief Scientific Officer of Radius Health. “The study will also include specialized high-resolution imaging to examine the effect of abaloparatide on bone structure, such as the hip, in a subset of the study participants.”

The primary endpoint of the male osteoporosis study is change in lumbar spine bone mineral density (BMD) at 12 months compared with placebo. The randomized, double-blind, placebo-controlled trial will enroll approximately 225 men with osteoporosis.

Tymlos is currently indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Tymlos was approved in April of 2017 and has three patents with expiration dates in 2027 and 2028. The new chemical entity (NCE) exclusivity expires on 4/28/2022.