Investigational drug product candidate abaloparatide-SC
In 2018, we initiated a Phase 3 study (ATOM), assessing the efficacy and safety of abaloparatide injection for the treatment of osteoporosis in men. The randomized, double-blind, placebo-controlled trial enrolled a total of 228 men with osteoporosis. In October 2021, Radius announced positive topline results from the ATOM trial.
Investigational drug product candidate abaloparatide-TD
We are developing an abaloparatide transdermal system (“abaloparatide-TD”), for potential use in the treatment of postmenopausal women with osteoporosis. In August 2019, we initiated our Phase 3 wearABLe study of abaloparatide-TD, a single, pivotal, randomized, open label, active-controlled, bone mineral density (“BMD”) non-inferiority bridging study with a planned enrollment of approximately 470 patients with postmenopausal osteoporosis at high risk of fracture, which if successful, will support an NDA submission.
A Randomized, Non-inferiority, Phase 3, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women With Osteoporosis (the wearABLe Study)
Investigational drug product candidate elacestrant
Elacestrant is a selective estrogen receptor degrader (SERD) out-licensed to Menarini Group which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.
In 2018 we initiated and opened for enrollment a Phase 3 study (EMERALD) evaluating elacestrant as second- or third-line monotherapy in postmenopausal women with advanced/metastatic estrogen receptor positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients. The study achieved its enrollment target of 466 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. In October 2021, the Radius and Menarini group jointly announced positive topline results from the EMERALD trial.
Investigational drug product candidate RAD011
In 2021 Radius announced the acquisition of the global development and commercialization rights to RAD011, a synthetic cannabidiol oral solution, from Benuvia Therapeutics Inc.
Over 150 patients have participated in clinical trials with RAD011 across multiple indications. Radius plans to initiate a pivotal Phase 2/3 study for patients with Prader-Willi syndrome (PWS) in the second half of 2021 pending regulatory discussion with the U.S. Food and Drug Administration (FDA). The study design will be informed by learnings from RAD011’s effect on hyperphagia and weight in the PWS patient population, and previous clinical studies. RAD011 was granted Fast Track Designation in 2017 and Orphan Drug Designation in August 2020 for the treatment of hyperphagia behavior and weight loss in patients with PWS.
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