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Radius begins phase 3 study for wearable osteoporosis drug
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Radius Health has initiated enrollment for a phase 3 clinical trial to assess the safety and efficacy of a wearable abaloparatide-transdermal patch in the treatment of postmenopausal women with osteoporosis at high risk for fracture, the company announced in a press release.
Abaloparatide-patch was developed in a collaboration between Radius and 3M Co., with the application of 3M’s microstructured transdermal patch technology. The phase 3 “wearABLe” abaloparatide-patch study is the first study to evaluate treatment of a novel noninjectable delivery of an anabolic therapy.
Before initiating the study, Radius achieved a special protocol assessment (SPA) agreement with the FDA for the acceptability of the overall protocol design. An SPA agreement is an advanced declaration from the FDA that an uncompleted phase 3 trial’s design, clinical endpoints and statistical analyses are acceptable for FDA approval, according to the agency.
“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,” Jesper Høiland, president and CEO Radius Health, said in the release. “We are excited about the encouraging results from our patient assessment study and about receiving an SPA agreement from the FDA, which provides us with a clearly defined and further de-risked development and regulatory pathway for our pivotal program.”
The wearABLe phase 3 study is a randomized, open-label, active-controlled, bone mineral density, noninferiority bridging study that will evaluate the efficacy and safety of abaloparatide-patch vs. abaloparatide injection (Tymlos) in approximately 470 patients with postmenopausal osteoporosis at high risk for fracture, according to the release. The primary endpoint of the study is the percentage of change in lumbar spine BMD at 12 months.
“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,” Aaron Mann, president and general manager of drug delivery systems for 3M Co., said in the release. “We are driven to develop patient-friendly delivery systems that enable our partners to bring their therapies to populations in need.”
In July, Radius obtained preliminary results from the abaloparatide-patch patient assessment study, which evaluated self-administration of abaloparatide-patch over 29 days in 22 postmenopausal women with low BMD. Researchers observed patients at a study site on the first, 15th and 29th day. Top-line results showed patients followed instructions for use and applied patches with a 99.7% success rate. The data also measured patient acceptability and indicated changes in patient procollagen type 1 N-terminal propeptide (P1NP) levels.
In an exploratory assessment, researchers found that an increase in P1NP levels between baseline and 1 month were consistent with values seen with abaloparatide injection at 1 month in the phase 3 ACTIVE trial. At baseline, median P1NP level was 50.5 ng/mL, increasing to a median value of 100.1 ng/mL at day 29. The median P1NP values observed with abaloparatide injection in the ACTIVE study were 50.6 ng/mL at baseline and 100.5 ng/mL at 1 month.
The wearABLe phase 3 study is open for enrollment at multiple clinical sites. Radius plans to complete patient recruitment by the end of 2019, according to the release. – by Regina Schaffer
Disclosures: Høiland is president and CEO Radius. Mann is president and general manager of drug delivery systems for 3M Co.
Perspective
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Robert Blank, MD, PhD
This study addresses one of the important barriers to anabolic therapy to prevent fractures, namely, the need for self-injection. This is an issue for patients being considered for either teriparatide (Forteo, Eli Lilly) or abaloparatide, who, in general, are those judged to be at highest fracture risk. Until the recent approval of romosozumab (Evenity, Amgen), these were the only anabolic therapies, and both require daily subcutaneous injection. Demonstration of effective delivery of abaloparatide via patch would obviate a common reason for refusal to accept anabolic therapy. The community eagerly awaits the result of this study.
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