WALTHAM, MA, USA I August 28, 2014 I Radius Health, Inc. (“Radius”) (RDUS), a science-driven biopharmaceutical company focused on developing novel differentiated therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases, reports that the positron emission tomography (PET) imaging from the RAD1901 maximum tolerated dose study (“MTD”) has demonstrated potent selective estrogen receptor degradation (“SERD”) activity. In the ongoing MTD study, we observed via 18F-fluroestradiol positron emission tomography that a well tolerated dose of RAD1901 strongly suppressed positive baseline estrogen receptor imaging sites in the first healthy volunteer in the PET imaging cohort of the study. The study will continue to test higher doses to determine the maximum tolerated doses and to extend the PET imaging correlation with the pharmacokinetic/pharmacodynamic response to RAD1901.

Radius will present these findings as a RAD1901 poster at the 4th Annual Brain Metastases Research and Emerging Therapy Conference, which takes place on September 19-20, 2014 in Marseille, France.

Title: RAD1901, A Novel Tissue-Selective Estrogen Receptor Degrader (SERD) Optimized For Blood-Brain Barrier

Presentation date: September 19th, 2014, 18:00 hours

About RAD1901

In June 2014, Radius initiated a Phase 1 MTD study in healthy volunteers, RAD1901, a SERD, for the treatment of metastatic breast cancer, including breast cancer brain metastases (“BCBM”). The study is designed to evaluate the tolerability, safety and pharmacokinetics of RAD1901, and also use 18F-fluroestradiol positron emission tomography to provide a pharmacodynamic assessment of estrogen receptor turnover following RAD1901 treatment. Levels of RAD1901 in cerebrospinal fluid samples taken from the study subjects will be measured to confirm that RAD1901 has crossed the blood brain barrier. Radius believes there is a significant therapeutic opportunity for RAD1901 as it may offer the following advantages over the current standard of care for patients with metastatic breast cancer:

  • ability to penetrate the blood-brain barrier;
  • oral administration; and
  • treatment of hormone driven, or hormone resistant, metastatic breast cancers.

Radius is also developing RAD1901 as a selective estrogen receptor modulator, or SERM, for the treatment of vasomotor symptoms. In a Phase 2 proof of concept study, RAD1901 at lower doses demonstrated a reduction in the frequency and severity of moderate and severe hot flashes.

Anticipated Upcoming Corporate Milestones

  • Abaloparatide-SC
    • Report of top-line fracture data from Abaloparatide-SC Phase 3 clinical study in late December 2014.
    • Submit a New Drug Application/NDA and a European Marketing Authorization Application/MAA for Abaloparatide-SC in mid-2015.
  • RAD1901
    • Initiate a Phase 1 clinical study of RAD1901 in metastatic breast cancer in late 2014.
    • Report results of MTD study in RAD1901.
  • Presentations
    • American Society of Bone and Mineral Research 2014 annual meeting in September 2014.
    • 4th Annual Brain Metastases Research and Emerging Therapy Conference September 19-20, 2014.
    • BioCentury Annual NewsMakers Conference (September 2014), BIO Investor Forum (October 2014) and Jefferies 2014 Global Healthcare Conference (November 2014).

About Radius Health

Radius Health, Inc. is a science-driven biopharmaceutical company developing novel differentiated therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases. The company’s lead development candidate is abaloparatide (BA058) for subcutaneous injection, currently in Phase 3 development for the reduction of fracture risk in postmenopausal women with severe osteoporosis. The Radius clinical portfolio also includes an abaloparatide transdermal patch for osteoporosis and RAD1901 for hormone driven, or hormone resistant, metastatic breast cancer, including breast cancer brain metastases. www.radiuspharm.com.

SOURCE: Radius Health