Radius Health Announces Positive Data On Lead Drug Tymlos
Zacks Investment Research | Mar 18, 2018 09:52PM ET
Radius Health, Inc. (NASDAQ:RDUS) announced positive results from the phase III study, ACTIVExtend, at ENDO 2018, the Endocrine Society's 100th Annual Meeting and Expo in Chicago.
The phase III study, ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial was a randomized, double-blind, placebo-controlled, comparative, multicenter, 18-month international study in 2,463 postmenopausal women with osteoporosis. The study evaluated the efficacy and safety of abaloparatide-SC 80 mcg to reduce the risk of vertebral and nonvertebral fractures. ACTIVExtend is an extension of the ACTIVE trial. The trial enrolled patients who completed 18 months of abaloparatide-SC or placebo in ACTIVE to receive up to 24 additional months of open-label alendronate.
Patients who completed 18 months of Tymlos injection or placebo in the ACTIVE trial were transitioned to receive 24 additional months of open-label alendronate, a bisphosphonate.
Bone Mineral Density (“BMD”) was measured at the lumbar spine, total hip, and femoral neck from the beginning of ACTIVE to the end of ACTIVExtend. Results showed that BMD response rates increased in both the abaloparatide followed by alendronate group and the placebo followed by alendronate group from ACTIVE baseline through the 43 months of ACTIVExtend. Additionally, greater BMD response rates of more than 0%, 3% and 6% were noted in the abaloparatide followed by alendronate group versus the placebo followed by alendronate group at all three sites combined at 43 months. At each anatomic site, BMD increases of more than 3% and 6% were noted respectively at each visit and at 43 months.
60.7% of abaloparatide followed by alendronate patients experienced BMD increases of more than 3 % at all three sites as compared with 24% of patients who received placebo followed by alendronate. The results from the ACTIVExtend Responder Analysis are consistent with the significant BMD response with Tymlos versus placebo observed in ACTIVE trial.
We remind investors that in April 2017, the FDA approved Tymlos (abaloparatide -SC) for the treatment of postmenopausal women with high risk osteoporosis for fracture — defined as history of osteoporotic fracture — multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
Radius Health’s shares have moved up 3.9% in the last six months compared with the Original post
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