March 16, 2016 8:30am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced dosing of the first subject
in a Phase 1 single dose escalation study evaluating the safety and
pharmacokinetics of a long-acting Oxyntomodulin (MOD-6031) in healthy,
overweight or obese subjects. The study is intended to enroll 40
subjects in Israel.
Oxyntomodulin is a peptide hormone that acts as a dual GLP-1/Glucagon
receptor agonist, with the potential to promote weight loss while
improving glycemic control. Oxyntomodulin has been shown to increase
energy expenditure, while reducing food intake and body weight, although
its clinical utility is limited by its short circulating half-life.
OPKO’s MOD-6031 has been designed, using a proprietary bi-functional
hydrolysable linker, as a long-acting version of Oxyntomodulin for the
treatment of Type II Diabetes and obesity, and is intended to reduce the
required dosage frequency by prolonging the half-life, while improving
the hormone's pharmacokinetics and pharmacodynamics.
About OPKO Health, Inc.
OPKO Health, Inc. is a diversified healthcare company that seeks to
establish industry-leading positions in large, rapidly growing markets.
Our diagnostics business includes Bio-Reference Laboratories, the
nation's third-largest clinical laboratory with a core genetic testing
business and a 420-person sales force 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™, a treatment for SHPT in stage 3-4 CKD patients with vitamin D
insufficiency (March 29, 2016 PDUFA date) and VARUBI™ for
chemotherapy-induced nausea and vomiting (oral formulation launched by
partner TESARO and NDA filed for IV formulation). Our biologics business
includes hGH-CTP, a once-weekly human growth hormone injection (in Phase
3 and partnered with Pfizer), and a long-acting Factor VIIa drug for
hemophilia (entering Phase 2a). We also have production and distribution
assets worldwide, multiple strategic investments and an active business
development strategy. More information is available at www.opko.com .
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), 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 expectations about our
long-acting Oxyntomodulin, expectations about market potential for
Oxyntomodulin, whether we will be able to successfully develop, obtain
approval for and launch sales of Oxyntomodulin, and the expected
completion dates for our trials. 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 clinical
trials for Oxyntomodulin may not be successful or achieve the expected
results or effectiveness, and 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
Oxyntomodulin, and that Oxyntomodulin may not have advantages or prove
to be superior over presently marketed products. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160316005711/en/
OPKO Health, Inc.
Tara Mackay, 305-575-4100
Investor Relations
or
Media
Rooney
& Associates
Terry Rooney, 212-223-0689
or
Marion
Janic, 212-223-4017
or
Investors
LHA
Anne
Marie Fields, 212-838-3777
or
Bruce
Voss, 310-691-7100
Source: OPKO Health, Inc.
Released March 16, 2016
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