Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics in the areas of osteoporosis and oncology.
The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis; an investigational abaloparatide patch for potential use in osteoporosis; the investigational drug elacestrant (RAD1901) for potential use in hormone-receptor positive breast cancer; and the investigational drug RAD140 under investigation for potential use in hormone-receptor positive breast cancer.
Our Investigational Product Candidates
The following table identifies the investigational product candidates in our current pipeline portfolio, their proposed indication and stage of development:
Investigational drug product candidate abaloparatide-SC
In 2018 we initiated a phase 3 study of abaloparatide injection for the treatment of osteoporosis in men. The randomized, double-blind, placebo-controlled trial will enroll approximately 225 men with osteoporosis. 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.
Investigational drug product candidate abaloparatide-patch
We are developing an abaloparatide transdermal patch (“abaloparatide-patch”), for potential use in the treatment of postmenopausal women with osteoporosis. In August 2019, we initiated our Phase 3 wearABLe study of abaloparatide-patch, 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) 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 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 will enroll approximately 460 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor.
Investigational drug product candidate RAD140
RAD140 is an internally discovered nonsteroidal selective androgen receptor modulator (SARM). The androgen receptor (AR) is frequently expressed in many estrogen receptor (ER)-positive, ER-negative, and triple-negative breast cancers. In 2017, we initiated a Phase 1 study of RAD140 in postmenopausal women with hormone-receptor positive, locally advanced or metastatic breast cancer.