FDA Authorizes OPKO Health Clinical Trial Evaluating RAYALDEE in COVID-19 Patients
June 01 2020 - 8:00AM
OPKO Health, Inc. (NASDAQ: OPK) today announced
that the U.S. Food and Drug Administration (FDA) has authorized
OPKO to undertake a Phase 2 trial with RAYALDEE® as a treatment for
patients with mild-to-moderate COVID-19. The trial, entitled
“A Randomized, Double-Blind Placebo-Controlled Study to Evaluate
the Safety and Efficacy of
RAYALDEE (calcifediol)
Extended-relea
se
Caps
ul
es to
Treat Symptomatic Patients Infected with SARS-CoV-2
(
REsCue),” is estimated to enroll 166 subjects,
including many with stage 3 or 4 chronic kidney disease (CKD).
The REsCue trial will have 4 weeks of treatment with RAYALDEE or
placebo and 2 weeks of follow-up. The objective is to raise
and maintain serum total 25-hydroxyvitamin D (25D) within the range
of 50-100 ng/mL in order to mitigate COVID-19 severity.
“Raising serum 25D enables macrophages, a type of white blood
cell of the immune system, to secrete potent antiviral proteins
that can destroy SARS-CoV-2, the virus that causes COVID-19,”
explained Charles W. Bishop, PhD, CEO of OPKO’s Renal Division.
“It also can suppress the cytokine storm triggered by viral
infection.”
COVID-19 disproportionately afflicts patients with obesity,
older age, darker skin or CKD, all of which are risk factors for
reduced serum 25D. Raising 25D sufficiently with supplements is
difficult.
About RAYALDEE®
RAYALDEE is an extended-release oral formulation of calcifediol,
a prohormone of calcitriol, the active form of vitamin D3.
The product is the first and only medicine approved by the U.S. FDA
for raising serum total 25D and lowering blood levels of intact
parathyroid hormone (iPTH). RAYALDEE, approved to treat secondary
hyperparathyroidism (SHPT) in adults with stage 3 or 4 CKD and
vitamin D insufficiency, was launched in November 2016.
About OPKO Health, Inc.
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
www.opko.com.
Cautionary Statement Regarding Forward-Looking
Statements This press release contains "forward-looking
statements," as that term is defined under the Private Securities
Litigation Reform Act of 1995 (PSLRA), which statements may be
identified by words such as "expects," "plans," "projects," "will,"
“could,” "may," "anticipates," "believes," "should," "intends,"
"estimates," and other words of similar meaning, including product
development efforts and the expected benefits of RAYALDEE, whether
and when we will initiate and complete the clinical studies
contemplated for RAYALDEE and whether final study data will be
positive, our ability to develop and commercialize RAYALDEE for
COVID-19 patients, whether RAYALDEE is capable of treating patients
with COVID-19, impacting the SARS-CoV-2 virus or cytokine storm, or
have any impact on the severity of the disease or that it will
effectively raise and maintain serum total 25D consistently at or
above 50ng/mL, as well as other non-historical statements about our
expectations, beliefs or intentions regarding our business,
technologies and products, financial condition, strategies or
prospects. 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 Annual Reports on Form 10-K filed and to be
filed with the Securities and Exchange Commission and in our other
filings with the Securities and Exchange Commission, as well as
liquidity issues and the risks inherent in funding, developing and
obtaining regulatory approvals of new, commercially-viable and
competitive products and treatments, the success of our
relationship with our commercial partners for RAYALDEE, that
earlier clinical results of effectiveness and safety may not be
reproducible or indicative of future results, and that currently
available over-the-counter and prescription products, as well as
products under development by others, may prove to be as or more
effective than our products for the indications being studied. 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.
CONTACTS: Investors LHA
Investor Relations Yvonne Briggs,
310-691-7100ybriggs@lhai.comorBruce Voss, 310-691-7100
bvoss@lhai.com
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