-Post-hoc analysis suggests abaloparatide may be
useful in the treatment of women with postmenopausal osteoporosis
and concurrent osteoarthritis, at high risk for fracture-
Radius Health, Inc. (Nasdaq: RDUS), a science-driven fully
integrated biopharmaceutical company that is committed to
developing and commercializing innovative endocrine therapeutics in
the areas of osteoporosis and oncology, today presented a post-hoc
analysis of Phase 3 data from different patient populations
included in the ACTIVE trial, and results from preclinical studies
of abaloparatide and its effect on the development and growth of
osteoclasts and on bone resorption during an oral session at ENDO
2019, the Endocrine Society’s Annual Meeting and Expo in New
Orleans, LA.
The first oral presentation titled “The Effect of Abaloparatide
on Bone Mineral Density and Fracture Incidence in Postmenopausal
Women with Osteoporosis and Osteoarthritis,” showed that in a
subpopulation of postmenopausal women from the ACTIVE study who
also had osteoarthritis (OA), abaloparatide was associated with
significant reduction in new vertebral fractures as well as
significant improvements in bone mineral density (BMD), versus
placebo.
The relationship between OA and osteoporosis is unclear but
increased risk of fragility fracture has been associated with OA
despite those patients having higher than average BMD. Of the 2,463
women enrolled in the Phase 3 ACTIVE trial, 888 patients with
ongoing OA were identified. The most common sites of OA were at the
spine (n=348, 39.2 percent) and knee (n=338, 38.1 percent). At 18
months, significant increases (P<0.0001) in BMD from baseline
were observed for abaloparatide versus placebo at the total hip
(mean change 3.17 percent versus -0.35 percent), femoral neck (2.81
percent versus -0.36 percent), and lumbar spine (8.78 percent
versus 0.86 percent); which was consistent with the overall ACTIVE
population results.
“Many patients with osteoporosis also have osteoarthritis. This
post-hoc analysis of the pivotal ACTIVE clinical trial provides
important information regarding the effects of abaloparatide in
this patient population,” said John P. Bilezikian, M.D., Chief,
Emeritus, of the Division of Endocrinology and Director, Emeritus,
of the Metabolic Bone Diseases Program at the Vagelos College of
Physicians and Surgeons, Columbia University Medical Center.
“Results from this analysis suggest abaloparatide may be useful as
a therapy of postmenopausal women with osteoporosis who also have
osteoarthritis and are at high risk for fracture.”
The second oral presentation titled “Different Effects of
Abaloparatide and hPTH(1-34) on Osteoclastogenesis and Bone
Resorption” used data from preclinical studies of abaloparatide.
The analysis provides mechanistic explanations for the net bone
gain observed in the ACTIVE trial, indicating that increased bone
mass is, at least partly, the consequence of reduced osteoclast
(bone resorption) activity.
“We’re pleased to share this new analysis in women who have
postmenopausal osteoporosis and osteoarthritis, as well as data
from preclinical studies that may explain the increased bone mass
observed in abaloparatide-treated patients,” said Bruce Mitlak,
M.D., Vice President of Clinical Development at Radius Health. “We
are committed to providing information about abaloparatide to help
inform treatment decisions for healthcare professionals managing
women with postmenopausal osteoporosis.”
Separately, Radius Health will present a poster titled: “Effect
of Abaloparatide on Bone Mineral Density and Fracture Incidence in
a Subset of Younger Postmenopausal Women with Osteoporosis at High
Risk for Fracture Representative of Covered Commercial Insurance
Enrollees.”
About Postmenopausal OsteoporosisOsteoporosis
is a silent disease, often displaying no signs or symptoms until a
fracture occurs, leaving a majority of patients undiagnosed and
undertreated. Osteoporotic fractures create a significant
healthcare burden, and represent a significant unmet medical need.
The majority (71 percent) of osteoporosis-related fractures in the
U.S. among those 50 and older occur in women.
The National Osteoporosis Foundation (NOF) has estimated that
nearly 8.2 million women in the U.S. over the age of 50 have
osteoporosis, and nearly one in two women over the age of 50 will
have a fragility fracture (or low-impact fracture that is often the
result of a fall from standing height or lower) in her remaining
lifetime.
The annual incidence of osteoporotic fractures is higher than
that of stroke, heart attack and breast cancer combined;
osteoporotic fractures also account for more hospitalizations and
associated costs than cardiovascular disease and breast cancer.
About TYMLOS (abaloparatide)
injectionTYMLOS® (abaloparatide) injection was
approved by the U.S. Food and Drug Administration for the
treatment of postmenopausal women with osteoporosis at high risk
for fracture defined as a history of osteoporotic fracture,
multiple risk factors for fracture, or patients who have failed or
are intolerant to other available osteoporosis therapy. Radius also
is developing abaloparatide-patch based on 3M
Company's patented Microstructured Transdermal System
technology for potential use as a treatment for postmenopausal
women with osteoporosis.
About ACTIVE The Phase 3 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 designed to evaluate the efficacy and safety of
abaloparatide-SC 80 mcg to reduce the risk of vertebral and
nonvertebral fractures. The results of ACTIVE were published in the
Journal of the American Medical Association in August of 2016.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF OSTEOSARCOMA
- Abaloparatide caused a dose-dependent increase in the
incidence of osteosarcoma (a malignant bone tumor) in male and
female rats. The effect was observed at systemic exposures to
abaloparatide ranging from 4 to 28 times the exposure in humans
receiving the 80 mcg dose. It is unknown if TYMLOS will cause
osteosarcoma in humans.
- The use of TYMLOS is not recommended in patients at
increased risk of osteosarcoma including those with Paget's disease
of bone or unexplained elevations of alkaline phosphatase, open
epiphyses, bone metastases or skeletal malignancies, hereditary
disorders predisposing to osteosarcoma, or prior external beam or
implant radiation therapy involving the skeleton.
- Cumulative use of TYMLOS and parathyroid hormone
analogs (e.g., teriparatide) for more than 2 years during a
patient's lifetime is not recommended.
Orthostatic Hypotension: Orthostatic
hypotension may occur with TYMLOS, typically within 4 hours of
injection. Associated symptoms may include dizziness, palpitations,
tachycardia or nausea, and may resolve by having the patient lie
down. For the first several doses, TYMLOS should be administered
where the patient can sit or lie down if necessary.
Hypercalcemia: TYMLOS may cause hypercalcemia.
TYMLOS is not recommended in patients with pre-existing
hypercalcemia or in patients who have an underlying hypercalcemic
disorder, such as primary hyperparathyroidism, because of the
possibility of exacerbating hypercalcemia.
Hypercalciuria and Urolithiasis: TYMLOS may
cause hypercalciuria. It is unknown whether TYMLOS may exacerbate
urolithiasis in patients with active or a history of urolithiasis.
If active urolithiasis or pre-existing hypercalciuria is suspected,
measurement of urinary calcium excretion should be considered.
Adverse Reactions: The most common adverse
reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea,
headache, palpitations, fatigue, upper abdominal pain and
vertigo.
INDICATIONS AND USAGETYMLOS is indicated for
the treatment of postmenopausal women with osteoporosis at high
risk for fracture defined as a history of osteoporotic fracture,
multiple risk factors for fracture, or patients who have failed or
are intolerant to other available osteoporosis therapy. In
postmenopausal women with osteoporosis, TYMLOS reduces the risk of
vertebral fractures and nonvertebral fractures.
Limitations of Use
Because of the unknown relevance of the rodent osteosarcoma
findings to humans, cumulative use of TYMLOS and parathyroid
hormone analogs (e.g., teriparatide) for more than 2 years during a
patient's lifetime is not recommended.
For the TYMLOS prescribing information, including Boxed Warning,
please visit www.tymlospi.com.
About RadiusRadius 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 U.S.
Food and Drug Administration for the treatment of
postmenopausal women with osteoporosis at high risk for fracture.
The Radius clinical pipeline includes an investigational
abaloparatide patch for potential use in osteoporosis; the
investigational drug elacestrant (RAD1901) for potential use in
hormone-receptor positive breast cancer; and the investigational
drug RAD140, a non-steroidal, selective androgen receptor modulator
(SARM) under investigation for potential use in hormone-receptor
positive breast cancer. For more information, please
visit www.radiuspharm.com.
Forward-Looking StatementsThis 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 incidence of
osteoporotic fractures and the health burden associated with
osteoporosis; and the potential clinical uses and therapeutic and
other benefits of our product candidates, including
abaloparatide-patch, elacestrant and RAD140.
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 collaborations 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 our product
candidate claims; the risk that adverse side effects will be
identified during the development of our 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 Securities and Exchange Commission,
or SEC, including under the caption “Risk Factors” in our
Annual Report on Form 10-K for the year ending December 31,
2018 and subsequent filings with the SEC, could cause
actual results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent management's estimates as of
the date of this press release. While we may elect to update
such forward-looking statements at some point in the future, we
disclaim any obligation to do so, even if subsequent events cause
our views to change. These forward-looking statements should
not be relied upon as representing our views as of any date
subsequent to the date of this press release.
Media Contact:Tiffany H. BurkeEmail:
tburke@radiuspharm.comPhone: 484-582-6476
Radius Recycling (NASDAQ:RDUS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Radius Recycling (NASDAQ:RDUS)
Historical Stock Chart
From Apr 2023 to Apr 2024