Phase 3 Data Supporting Rayaldee™ As a Treatment for Secondary Hyperparathyroidism in Chronic Kidney Disease to be Presente...
March 27 2015 - 9:12AM
Business Wire
OPKO Health, Inc. (NYSE: OPK), today announced the presentation
of additional phase 3 clinical data in a poster at the National
Kidney Foundation’s Spring Clinical Meetings on March 27-28th, 2015
in Dallas, Texas, that will include data for 429 patients
completing up to twelve months of treatment in OPKO’s phase 3
trials for Rayaldee as a treatment for secondary
hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic
kidney disease (CKD) and vitamin D insufficiency. The data to be
presented will highlight the unexpected finding that responses to
Rayaldee treatment are as good in patients with stage 4 CKD as they
are in stage 3 CKD. The data support the conclusion that Rayaldee
effectively controls SHPT through the correction of vitamin D
insufficiency irrespective of CKD severity.
OPKO’s poster presentation is entitled: “Modified-Release
Calcifediol Is Effective for SHPT in Both Stages 3 and 4 CKD.”
Session details: March 27-28, No. 156; Category:
CKD/ESRD-Mineral Metabolism and Kidney Stones.
About RayaldeeTM
Rayaldee is a first-in-class oral vitamin D prohormone treatment
being developed for SHPT in patients with stage 3 or 4 CKD and
vitamin D insufficiency. It has a proprietary modified-release
formulation designed to gradually and reliably raise serum total
25-hydroxyvitamin D (prohormone) concentrations to targeted levels
(at least 30 ng/mL) while avoiding upregulation of CYP24, a
cytochrome P-450 enzyme that reduces the parathyroid hormone
(PTH)-lowering potency of current vitamin D supplements. Activation
of calcifediol, the active ingredient in Rayaldee, by the kidney is
tightly regulated, preventing excessive elevation of serum calcium
and related side effects which limit the value of current vitamin D
hormone therapies by promoting vascular and renal calcification.
Rayaldee is expected to address the approximately 8 million
patients in the U.S., and many more elsewhere, with stage 3 or 4
CKD, SHPT and vitamin D insufficiency.
About Chronic Kidney Disease
CKD is a condition characterized by a progressive decline in
kidney function. The kidney is normally responsible for excreting
waste and excess water from the body, and for regulating various
hormones. CKD is classified in five different stages — mild (stage
1) to severe (stage 5) disease — as measured by the kidney's
glomerular filtration rate. According to the National Kidney
Foundation, CKD afflicts over 26 million people in the U.S.,
including more than 20 million patients with moderate (stages 3 or
4) and severe (stage 5) forms of CKD. In stage 5 CKD, kidney
function is minimal to absent and patients require regular dialysis
or a kidney transplant for survival.
About Vitamin D Insufficiency
Vitamin D insufficiency is a condition in which the body has low
vitamin D stores, characterized by inadequate blood levels of
vitamin D prohormone, known as 25-hydroxyvitamin D. An estimated
70-90% of CKD patients have vitamin D insufficiency, which can lead
to SHPT and resultant debilitating bone diseases. Vitamin D
insufficiency has been associated with increased mortality in
CKD.
About Secondary Hyperparathyroidism (SHPT)
SHPT is a condition commonly associated with CKD in which the
parathyroid glands secrete excessive amounts of PTH. SHPT arises as
a result of vitamin D insufficiency or impaired kidney function
that prevents sufficient production of vitamin D hormone to
properly regulate calcium and phosphorus metabolism, and PTH
secretion. Prolonged elevation of blood PTH causes excessive
calcium and phosphorus to be released from bone, leading to
elevated serum calcium and phosphorus, softening of the bones
(osteomalacia) and calcification of vascular and renal tissues.
SHPT affects 40-60% of patients with moderate CKD and approximately
90% of patients with severe CKD. Vitamin D therapy for SHPT is
associated with reduced mortality in CKD patients.
About OPKO
OPKO is a multinational biopharmaceutical and diagnostics
company that seeks to establish industry leading positions in
large, rapidly growing markets by leveraging its discovery,
development and commercialization expertise and novel and
proprietary technologies. For more information, visit
http://www.opko.com.
This press release contains "forward-looking statements," as
that term is defined under the Private Securities Litigation Reform
Act of 1995 (PSLRA), regarding product development efforts and
other non-historical facts about our expectations, beliefs or
intentions regarding our business, technologies and products,
financial condition, strategies or prospects, including statements
regarding our ability to successfully launch and commercialize
proprietary renal disease products, expectations about Rayaldee,
that Rayaldee will effectively control secondary
hyperparathyroidism in patients with stage 3 or 4 chronic kidney
disease by correcting vitamin D insufficiency, whether Rayaldee is
appropriate for patients with minimal functioning kidney mass and
its efficacy during longer term administration, whether Rayaldee
will be highly effective in correcting vitamin D insufficiency,
allowing more reliable treatment of patients, whether it is the
solution to secondary hyperparathyroidism associated with vitamin D
insufficiency for the 20 million pre-dialysis CKD patients in the
U.S. and elsewhere, market potential for Rayaldee, that it will
address the approximately 8 million CKD stage 3 and 4 patients in
the U.S. and many more elsewhere, with SHPT and vitamin D
insufficiency, that Rayaldee will treat vitamin D insufficiency and
gradually correct elevated PTH, without safety concerns, and that
we will be able to successfully develop, obtain approval for and
launch sales of Rayaldee. Many factors could cause our actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements. These factors
include those described in our filings with the Securities and
Exchange Commission, as well as risks inherent in funding,
developing and obtaining regulatory approvals of new,
commercially-viable and competitive products and treatments,
including the risks that the phase 3 clinical trials for Rayaldee
may not generate data that would support the approval or marketing
of this product for the indications being studied, that others may
develop products which are superior to Rayaldee, and that Rayaldee
may not have advantages or prove to be superior over presently
marketed products, including the currently used high monthly doses
of prescription vitamin D2, activated vitamin D hormone and
over-the-counter vitamin D supplements. In addition,
forward-looking statements may also be adversely affected by
general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. The forward-looking statements contained in this press
release speak only as of the date the statements were made and we
do not undertake any obligation to update forward-looking
statements. We intend that all forward-looking statements be
subject to the safe-harbor provisions of the PSLRA.
OPKO Health, Inc.Charles Bishop, 305-575-4100
Opko Health (NASDAQ:OPK)
Historical Stock Chart
From Aug 2024 to Sep 2024
Opko Health (NASDAQ:OPK)
Historical Stock Chart
From Sep 2023 to Sep 2024