March 24, 2016 12:24pm EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced it will present 18-24 month
clinical data from its ongoing open label extension study for hGH-CTP in
an oral presentation at the Endocrine Society’s 98 th Annual
Meeting to be held April 1-4, 2016, in Boston, MA.
The open label extension study is a continuation of our phase 2 one-year
dose-finding study in which 53 naïve growth hormone deficient children
received one of three doses of hGH-CTP once weekly (0.25, 0.48 and 0.66
mg/kg/week ) or daily Genotropin® as a comparator arm (34 µg/kg/day ).
The published twelve-month data from the phase 2 study confirmed
comparable response of hGH-CTP to daily Genotropin® as reflected by the
twelve-month safety, efficacy and pharmacodynamic profile. Patients were
rolled into the open label extension portion of the study while the
daily arm patients were randomized to one of the hGH-CTP doses. For more
information on the phase 2 study, please refer to https://clinicaltrials.gov/ct2/show/NCT01592500 .
The oral presentation is scheduled for Sunday, April 3, 2016 at 11:45 AM
- 1:15 PM ET, Oral Session Number: OR31-6.
Based on the promising phase 2 clinical data, OPKO confirms its plan to
initiate a global pivotal phase 3 study in pre-pubertal growth
hormone-deficient children later this year evaluating a weekly single
dose of hGH-CTP versus daily injections of growth hormone. OPKO has a
world-wide collaboration agreement with Pfizer Inc. for the development
and commercialization of hGH-CTP.
Poster title
Poster ID + link
Safety and Tolerability of Once-Weekly Administration of
CTP-Modified
Human Growth Hormone (MOD-4023): Phase 2 Study in
SAT028
Children with Growth Hormone Deficiency
Evaluation of Pharmacokinetics and Pharmacodynamics of Long-Acting
Human Growth Hormone (MOD-4023) in Healthy
FRI
537
Caucasian and Japanese Adults
Pharmacokinetic and Pharmacodynamic Modeling of Long-Acting Human
SAT
029
Growth Hormone (MOD-4023) in Growth Hormone Deficient Children
When Should IGF-1 be Monitored during Weekly Administration of a
SAT
039
Long-Acting Human Growth Hormone (MOD-4023)?
Batch-to-Batch Consistency of a Highly O-Glycosylated Long-Acting
FRI
513
Human Growth Hormone (MOD-4023)
Robust Viral Clearance Capacity of CTP-Modified Long-Acting Growth
SAT
109
Hormone (MOD-4023) Downstream Production Process
In addition, the following poster presentations will include
non-clinical data characterizing Oxyntomodulin (MOD-6031), a novel long
acting dual GLP-1/Glucagon agonist for the induction of weight
management.
In Vitro Characterization of MOD-6031- a Novel Long Acting Dual
SUN
622
GLP-1/Glucagon Agonist for the Induction of Weight Management
Improved Glycemic Profile and Anti-Obesity Effects Alongside
Significant Elongated Pharmacokinetic Profile Following
Administration
SUN
621
of Mod-6031 - a Novel Long-Acting Dual GLP-1/Glucagon Agonist
Earlier this month, OPKO announced dosing of the first subject in a
phase 1 single dose escalation study evaluating the safety and
pharmacokinetics of a long-acting Oxyntomodulin in healthy, overweight
or obese subjects. The study is intended to enroll 40 subjects in Israel.
About hGH-CTP
hGH-CTP is a novel, long-acting recombinant human growth hormone analog
being developed by OPKO for the treatment of children with growth
failure due to inadequate endogenous growth hormone secretion, and
adults with growth hormone deficiency (GHD) of either childhood or
adult-onset etiology. hGH-CTP is intended to reduce the burden of daily
injection therapy.
OPKO's proprietary technology enables elongation of a therapeutic
protein's half-life without the use of polymers, encapsulation
techniques, or nanoparticles. This technology is based on a natural
peptide, the C-terminal peptide (CTP) of the beta chain of human
chorionic gonadotropin (hCG). hGH-CTP has been granted orphan drug
designation in the U.S. and Europe for both adults and children with
growth hormone deficiency.
About Oxyntomodulin
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. A MOD-6031 phase 1
study was recently initiated.
About OPKO Health
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), a long-acting Factor VIIa drug for
hemophilia (entering Phase 2a), and Oxyntomodulin for obesity and
diabetes (Phase 1). 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 .
SAFE HARBOR STATEMENT
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," "may," "anticipates," "believes," "should,"
"intends," "estimates," and other words of similar meaning, including
statements regarding expected timing of study completion, OPKO’s ability
to commence its phase 3 pediatric study for hGH-CTP later this year,
whether OPKO's clinical trials for hGH-CTP in adult and pediatric growth
hormone deficiency and Oxyntomodulin for diabetes and obesity will be
successful or generate data to support marketing approval, whether study
results will demonstrate hGH-CTP is non-inferior compared to daily hGH,
whether hGH-CTP or Oxyntomodulin will be successfully developed or
commercialized, expectations regarding the products and their market
potential, 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 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. 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, litigation, and the success of
our collaboration on hGH-CTP with Pfizer, Inc. 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/20160324005939/en/
OPKO Health, Inc.
Investor Relations, 305-575-4100
or
Rooney
& Associates
Terry Rooney, 212-223-0689
or
Marion
Janic, 212-223-4017
Source: OPKO Health, Inc.
Released March 24, 2016
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