Biopharmaceutical company Radius Health has completed enrolment in a Phase III study of BA058-subcutaneous as a treatment for osteoporosis in postmenopausal women at high risk of fracture.
The company is developing BA058, a bone-building synthetic peptide analog, in both subcutaneous (BA058-SC) and transdermal patch (BA058-TD) formulations.
Radius Health chief medical officer Dr Louis Brenner said; "We are grateful for the efforts of our patients, investigators, and research collaborators to bring the pivotal study of BA058-SC to this key point, and we look forward to their continued contributions through the treatment and follow-up phases of the study."
The Phase III trial for BA058-SC reached its enrolment target of 2,400 subjects, and final subjects entering the study have been randomised.
The double-blind trial’s primary endpoint is the efficacy of BA058-SC daily injection compared to placebo in preventing new vertebral fractures over 18 months of treatment.
Forteo, marketed by Eli Lilly, is an active comparator arm of the placebo-controlled study.
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The Center for Clinical and Basic Research founder, Nordic Bioscience board chairman and radius advisor Dr Claus Christiansen said; "We are excited to have contributed to the achievement of BA058’s research milestones and we are optimistic about the potential for BA058 to provide a novel anabolic treatment option for postmenopausal osteoporosis patients."
In a Phase II study, BA058-SC was safe and well tolerated, demonstraing a considerable increase in bone mineral density at the lumbar spine and femoral neck following six months of therapy in women with osteoporosis.