- Abaloparatide-Patch patient assessment study results demonstrated high patient acceptability and self-administration accuracy over a 29-day period
- Levels of PINP, a biomarker for bone formation, after one month in patient assessment study were consistent with results in Phase 3 ACTIVE study of TYMLOS® (abaloparatide) injection
- Abaloparatide-Patch SPA agreement with
FDAincludes a non-inferiority margin of 2% for the difference in percentage change in lumbar spine BMD at 12 months (i.e. preserves ~77% of the historical effect of TYMLOS)
Abaloparatide-patch was developed in a collaboration between Radius and
“The initiation of our Phase 3 wearABLe study of abaloparatide-patch is a major accomplishment toward our goal of increasing treatment options for postmenopausal osteoporosis patients at high risk for fracture by expanding the use of anabolic bone building therapies,” said Jesper Hoeiland, President & Chief Executive Officer of Radius. “We are excited about the encouraging results from our patient assessment study and about receiving an SPA agreement from the
“We are excited to reach this critical milestone in our successful strategic partnership with Radius, utilizing our innovative microstructured transdermal patch delivery technology in a potentially transformative treatment option for osteoporosis,” said
The wearABLe Phase 3 study is a pivotal, randomized, open label, active-controlled, bone mineral density (“BMD”) non-inferiority bridging study that will evaluate the efficacy and safety of abaloparatide-patch versus TYMLOS (abaloparatide injection) in approximately 470 patients with postmenopausal osteoporosis at high risk of fracture. The primary endpoint of the study is the percentage of change in lumbar spine BMD at 12 months. Non-inferiority of abaloparatide-patch to abaloparatide injection will be concluded if the lower bound of the 2-sided 95% confidence interval for the estimated treatment difference (abaloparatide-patch minus abaloparatide injection) in the percentage change from baseline in lumbar spine BMD at 12 months is above -2.0%. A non-inferiority margin of 2% preserves ~77% of the historical effect of TYMLOS based on the data from the Phase 3 ACTIVE Study which showed placebo-adjusted increase in lumbar spine BMD of 9.1% (95% CI: 8.6%, 9.6%) at 12 months.
The wearABLe Phase 3 study is currently open for enrollment at multiple clinical sites. Radius plans to complete patient recruitment in this study by the end of 2019.
Webcast and Conference Call
In connection with today’s announcement, Radius will host a conference call and live audio webcast at
Conference Call Information:
International Dial-in Number: (346) 406-0961
Conference ID: 5489050
Live webcast: https://edge.media-server.com/mmc/p/scqm3f4x
For those unable to participate in the conference call or webcast, a replay will be available from
A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement will also be available on the Company’s website.
About TYMLOS® (abaloparatide) injection
TYMLOS (abaloparatide) injection was approved by the
Important Safety Information
TYMLOS may cause serious side effects including possible bone cancer (osteosarcoma). During animal drug testing, TYMLOS caused some rats to develop a bone cancer called osteosarcoma. It is not known if people who take TYMLOS will have a higher chance of getting osteosarcoma.
It is not recommended that people use TYMLOS for more than 2 years during their lifetime.
TYMLOS can cause serious side effects including: Decrease in blood pressure when you change positions. Some people may feel dizzy, have a faster heartbeat, or feel lightheaded soon after the TYMLOS injection is given. These symptoms generally go away within a few hours; Increased blood calcium (hypercalcemia). TYMLOS can cause some people to have a higher blood calcium level than normal. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood; Increased urine calcium (hypercalciuria). TYMLOS can cause some people to have higher levels of calcium in their urine than normal. Increased calcium may also cause you to develop kidney stones (urolithiasis) in your kidneys, bladder or urinary tract.
The most common side effects of TYMLOS include dizziness, nausea, headache, fast heartbeat, feeling very tired (fatigue), upper stomach pain, and vertigo.
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. Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential benefits of the SPA agreement for abaloparatide-patch and results from the patient assessment study of abaloparatide-patch; our expectations for our Phase 3 study of abaloparatide-patch, including the timing for recruitment; and the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide-patch, elacestrant and RAD140, and our expectations regarding our clinical trials.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we expect to need to raise additional funding, which may not be available; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products; risks related to our ability to successfully enter into collaboration agreements and any executed collaboration agreements failing to be successful; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that results will support abaloparatide-patch or our other product candidate claims; the risk that adverse side effects will be identified during the development of abaloparatide-patch or our other product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the
Investor Relations & External Communications Contact:
Source: Radius Health Inc.