OPKO Health Initiates Clinical Trial of RAYALDEE in COVID-19 Patients
September 15 2020 - 7:00AM
OPKO Health, Inc. (NASDAQ: OPK) announces the
initiation of a Phase 2 trial with RAYALDEE® as a treatment for
mild-to-moderate COVID-19. The trial, “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 expected to enroll approximately 160
subjects, many with stage 3 or 4 chronic kidney disease (CKD) who
are at higher risk for developing more severe illness.
The trial will be conducted at multiple COVID-19 outpatient
clinics in the U.S. The initial sites are located primarily
in South Florida, the Central Gulf coast, the Midwest and the
Southwest. The first subjects are expected to be enrolled within
the next few weeks.
The REsCue trial will randomize COVID-19 outpatients in a 1:1
ratio to 4 weeks of treatment with RAYALDEE or placebo and 2 weeks
of follow-up. Dosing with RAYALDEE will commence with 300 mcg per
day on Days 1, 2 and 3 followed by 60 mcg per day on Days 4 through
27. Primary efficacy endpoints are raising and maintaining serum
total 25-hydroxyvitamin D (25D) within the range of 50-100 ng/mL
and time to resolution of COVID-19 symptoms. Secondary
endpoints include incidence of emergency room or urgent care
visits, oxygen saturation below 94%, need for and duration of
hospitalizations, requirement for mechanical ventilation, mortality
rate, and severity and duration of illness evidenced by
quality-of-life measures. More information about this trial
will soon become available on https://clinicaltrials.gov/.
Numerous independent studies have reported a correlation between
vitamin D status and COVID-19 risk and severity. OPKO expects
to report topline results from this Phase 2 trial before
year-end.
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.
Food and Drug Administration (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 including whether RAYALDEE could impact 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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