Radius is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases.
Radius’ lead product candidate, the investigational drug abaloparatide for subcutaneous injection, has completed Phase 3 development for potential use in the treatment of postmenopausal women with osteoporosis. Radius’ Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe and a New Drug Application (NDA) is under regulatory review in the US by the Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) date of March 30, 2017. The Radius clinical pipeline also includes an investigational abaloparatide transdermal patch for potential use in postmenopausal women with osteoporosis and the investigational drug RAD1901 for potential use in the treatment of hormone-driven and/or hormone-resistant breast cancer, as well as for potential use in the treatment of vasomotor symptoms in postmenopausal women. Radius’ preclinical pipeline includes RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in the treatment of breast cancer.
Established in 2003 by world-renowned researchers, our history is deeply rooted in science and our research and development efforts are focused on disease areas with significant unmet need for new treatment options to help improve the lives of patients.
Through collaborations and partnerships and our growing innovative pipeline, Radius is in position to expand into a fully integrated biopharmaceutical company with areas of expertise spanning from discovery and development to commercialization of its products.
Radius is committed to the research and development of new therapeutics for the large and underserved osteoporosis patient population. Our lead product candidate, the investigational drug abaloparatide, is a bone anabolic for potential use in the treatment of postmenopausal women with osteoporosis. We are developing two formulations of abaloparatide: abaloparatide-SC, an injectable subcutaneous formulation, and abaloparatide-TD, a line extension of abaloparatide-SC in the form of a convenient, short-wear-time transdermal patch.
Our clinical pipeline also includes the investigational drug RAD1901, a selective estrogen receptor degrader, or SERD, under investigation at high doses as a potential oral non-steroidal treatment for advanced hormone-driven, or hormone-resistant, breast cancer. Radius is conducting a Phase 1, multicenter, open-label, two-part, dose-escalation study of RAD1901 in postmenopausal women with advanced estrogen-receptor positive and HER2-negative breast cancer. Part A was initiated to evaluate escalating doses of RAD1901, and the Part B expansion cohort was initiated in March 2016 to allow for an evaluation of additional safety, tolerability and preliminary efficacy. In December 2015, we commenced a Phase 1 FES-PET study in patients with metastatic breast cancer in the European Union, which includes the use of FES-PET imaging to assess estrogen receptor occupancy in tumor lesions following RAD1901 treatment. RAD1901 is also being studied in a Phase 2b study at low doses for potential reduction in the frequency and severity of vasomotor symptoms (i.e., moderate to severe hot flashes) in postmenopausal women.
In addition, we are developing the investigational drug RAD140, a non-steroidal selective androgen receptor modulator, or SARM. RAD140 resulted from an internal drug discovery program focused on the androgen receptor pathway, which is highly expressed in many breast cancers. Due to its receptor and tissue selectivity, potency and long half-life, RAD140 could have clinical potential in the treatment of breast cancer or possibly other conditions where androgen modulation may offer potential therapeutic benefit.