OPKO Provides Update to Topline Data of Phase 3 Clinical Study of hGH-CTP in Growth Hormone Deficient Adults
15 June 2017 - 11:12PM
OPKO Health, Inc. (NASDAQ:OPK) announces an update
to the topline data analysis of the Phase 3, double-blind,
placebo-controlled study of its investigational long-acting human
growth hormone product (hGH-CTP) in adults with growth hormone
deficiency (GHD). In December 2016 OPKO reported that the primary
endpoint of change in trunk fat mass from baseline to 26 weeks did
not demonstrate a statistical difference between the hGH-CTP
treated group and placebo. At the time, one or more outliers were
identified that may have affected the outcome on the primary
endpoint.
OPKO has now completed post-hoc sensitivity analyses to evaluate
the influence of outliers on the primary endpoint results using
multiple statistical approaches. Analyses that excluded
outliers showed a statistically significant difference between
hGH-CTP and placebo on the change in trunk fat mass.
Additional analyses that did not exclude outliers showed mixed
results. Post-hoc analyses do not carry the same weight of evidence
as a pre-specified primary analysis.
“We are encouraged by the results of these analyses,” stated
Phillip Frost, M.D., OPKO Chairman and Chief Executive
Officer.
OPKO has initiated a global Phase 3 trial, utilizing a
multi-dose disposable pre-filled pen, to evaluate hGH-CTP in
pediatric GHD patients. OPKO also plans to utilize this multi-dose
pen for patients who continue in the open label extension phase of
the adult Phase 3 and the pediatric Phase 2 GHD studies. In
addition, preparation for the pivotal pediatric GHD trial in Japan
is progressing and site selection is near completion.
About OPKO Health, Inc.
OPKO Health is a diversified healthcare company that seeks to
establish industry leading positions in large, rapidly growing
markets. Our diagnostics business includes BioReference
Laboratories, the nation's third largest clinical laboratory with a
core genetic testing business and a 400 person sales and marketing
team to drive growth and leverage new products, including the
4Kscore® prostate cancer test and the Claros® 1 in office
immunoassay platform. Our pharmaceutical business features
RAYALDEE, an FDA approved treatment for SHPT in stage 3-4 CKD
patients with vitamin D insufficiency (launched in November 2016),
VARUBI™ for chemotherapy induced nausea and vomiting (oral
formulation launched by partner TESARO and IV formulation pending
FDA approval), OPK88004, a once or twice weekly oxyntomodulin for
type 2 diabetes and obesity, in Phase 2 clinical trials,
among the new class of GLP-1 glucagon receptor dual agonists,
and OPK88003, a selective androgen receptor modulator
for benign prostatic hyperplasia (Phase 2). Our
biologics business includes hGH-CTP, a once weekly human growth
hormone in Phase 3 and partnered with Pfizer; and a long-acting
Factor VIIa drug for hemophilia in Phase 2a. More information
available at www.opko.com.
SAFE HARBOR STATEMENTThis 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," "may," "anticipates," "believes,"
"should," "intends," "estimates," and other words of similar
meaning, including statements regarding expectations about hGH-CTP
and the results of the sensitivity analyses, expectations regarding
our ongoing and expected clinical studies for hGH-CTP, whether the
studies will be successfully completed and on a timely basis, and
whether data from our studies for hGH-CTP, including the post-hoc
sensitivity analyses, will support submission of a Biologics
License Application and approval for hGH-CTP, 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 the risks inherent in funding,
developing and obtaining regulatory approvals of new,
commercially-viable and competitive products and treatments. 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:
OPKO HealthTara Mackay, 305-575-4100tmackay@opko.comorDavid
Malina, 305-575-4137DMalina@opko.comInvestor Relations
or
MediaRooney PartnersTerry Rooney,
212-223-0689trooney@rooneyco.comorMarion Janic,
212-223-4017mjanic@rooneyco.com
or
InvestorsLHA Investor RelationsAnne Marie Fields,
212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
Opko Health (NASDAQ:OPK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Opko Health (NASDAQ:OPK)
Historical Stock Chart
From Apr 2023 to Apr 2024