SAN FRANCISCO, Feb. 25, 2015 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ: NKTR) today announced the enrollment of
the first patient in SUMMIT-07, its initial Phase 3 study of
NKTR-181, a first-in-class, opioid analgesic molecule with a slow
rate of entry into the brain. This slow rate of entry is
designed to reduce the euphoria that can lead to the abuse of
current opioid analgesics.1 SUMMIT-07 will
evaluate the efficacy, safety and tolerability of NKTR-181 in
patients with chronic low back pain who are also opioid-naïve (new
to treatment).
"With millions of patients suffering from chronic pain, there is
a clear unmet medical need for better and safer pain medications,"
said Dr. Nathaniel Katz, President
of Analgesic Solutions and Adjunct Asst. Professor of Anesthesia at
Tufts University School of Medicine.
"As a mu-opioid agonist designed to have anti-abuse properties
inherent to its molecular structure, NKTR-181 has the potential to
have an important impact on the growing health care crisis of
opioid abuse and diversion."
NKTR-181 is a new chemical entity (NCE) that was created using
Nektar's proprietary small molecule polymer conjugate technology.
NKTR-181 has several potential differentiating properties that are
inherent to the structure of the molecule, including a slow rate of
entry into the CNS as measured by pupillometry (contraction of the
pupils) and a plasma pharmacokinetic profile that supports
twice-daily oral dosing. NKTR-181 is not a reformulation of a
marketed opioid, which is a commonly-used method to attempt to
prevent the manipulation of existing long-acting opioid drugs into
more abusable forms.
"The investigators are pleased to see the start of this
important first study in the SUMMIT Phase 3 program to evaluate the
efficacy and safety of NKTR-181 in patients with chronic low back
pain," said Dr. Martin Hale, Medical
Director of Gold Coast Research, LLC. "NKTR-181 holds great
promise as it represents a completely new class of pain medicine
that could allow us to maintain the efficacy of traditional
opioids, while potentially reducing the risks of misuse, abuse and
diversion."
NKTR-181 has been granted has been granted Fast Track
designation for the treatment of moderate to severe chronic pain by
the U.S. Food and Drug Administration.
SUMMIT-07 Study Design
The SUMMIT-07 Phase 3 trial
utilizes an enriched-enrollment, randomized withdrawal (EERW)
design and will enroll opioid-naïve patients ages 18 to 75 years
who have had moderate to severe non-neuropathic chronic low back
pain for at least six months. The study includes an open-label,
dose titration period followed by a randomized, double-blind,
placebo-controlled 12 week treatment period. During the
open-label titration phase, study participants will be titrated on
NKTR-181 tablets administered orally twice daily until they
experience an adequate and sustained pain response. Patients who
achieve this will then be randomized on a 1:1 basis to either
continue to receive their analgesic dose of NKTR-181 or to receive
placebo during the double-blind 12 week treatment period. A
total of 208 patients will be randomized to each arm. No
background NSAIDs are allowed throughout the study.
The primary endpoint of the study is a change in pain as
measured by the change in a patient's weekly pain score from
baseline to week 12 of the randomized, double-blind treatment
period.
The SUMMIT Phase 3 program will also include a Phase 3 efficacy
and safety trial in patients who are opioid-experienced (SUMMIT-12)
as well as a 52-week long-term safety study (SUMMIT-LTS).
For more information on the SUMMIT-07 study, please visit
https://www.clinicaltrials.gov/ct2/show/NCT02362672?term=nktr-181&rank=2
About Opioids and Pain Management
Pain is one of the
most common reasons people seek medical treatment.i A
study published in the American Pain Society's The Journal of
Pain in October 2014 estimated
that 19 percent of the U.S. population, or 39 million people,
suffer from persistent pain.ii
Opioids are considered the most effective therapeutic option for
pain with 270 million prescriptions written in the U.S. alone in
2013.iii iv The global opioid market for
chronic pain, which includes chronic back pain, osteoarthritis,
fibromyalgia and neuropathic pain, is estimated to be $12.6 billion. Opioids can cause serious side
effects such as respiratory depression and sedation and have the
potential for addiction, abuse and misuse. According to the Centers
for Disease Control and Prevention (CDC), 420,040 emergency
department visits in 2011 were related to opioid
analgesics.v In the United
States, prescription opioid abuse costs were about
$55.7 billion in 2007, of which 46
percent was attributable to workplace costs (e.g., lost
productivity), 45 percent to healthcare costs (e.g., abuse
treatment), and 9 percent to criminal justice
costs.vi
About Nektar
Nektar Therapeutics has a robust R&D
pipeline in pain, oncology, hemophilia and other therapeutic areas.
In the area of pain, Nektar has an exclusive worldwide license
agreement with AstraZeneca for MOVANTIK™ (naloxegol), the first
FDA-approved once-daily oral peripherally-acting mu-opioid receptor
antagonist (PAMORA) medication for the treatment of opioid-induced
constipation (OIC), in adult patients with chronic, non-cancer
pain. The product is also approved in the European Union as
MOVENTIG® and is indicated for adult patients with OIC who have had
an inadequate response to laxatives. The AstraZeneca agreement also
includes NKTR-119, an earlier stage development program that is a
co-formulation of MOVANTIK™ and an opioid. NKTR-181, a wholly-owned
mu-opioid analgesic molecule for chronic pain conditions, is in
Phase 3 development. NKTR-171, a wholly-owned new sodium channel
blocker being developed as an oral therapy for the treatment of
peripheral neuropathic pain, is in Phase 1 clinical development. In
oncology, NKTR-102 is being evaluated in a Phase 3 clinical study
(the BEACON study) for the treatment of metastatic breast cancer.
In hemophilia, BAX 855, a longer-acting PEGylated Factor VIII
therapeutic is in Phase 3 development conducted by partner
Baxter. In anti-infectives,
Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare
as an adjunctive treatment for intubated and mechanically
ventilated patients with Gram-negative pneumonia.
Nektar's technology has enabled nine approved products in the
U.S. or Europe through
partnerships with leading biopharmaceutical companies, including
AstraZeneca's MOVANTIK™, UCB's Cimzia® for Crohn's disease and
rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's
Neulasta® for neutropenia.
Nektar is headquartered in San
Francisco, California, with additional operations in
Huntsville, Alabama and
Hyderabad, India. Further
information about the company and its drug development programs and
capabilities may be found online at http://www.nektar.com.
MOVANTIK™ is a trademark of the AstraZeneca group of
companies.
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by words such
as: "anticipate," "intend," "plan," "expect," "believe," "should,"
"may," "will" and similar references to future periods. Examples of
forward-looking statements include, among others, statements we
make regarding the therapeutic potential of NKTR-181 and the value
and potential of our technology and research and development
pipeline. Forward-looking statements are neither historical facts
nor assurances of future performance. Instead, they are based only
on our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, anticipated
events and trends, the economy and other future conditions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict and many of which are outside of our
control. Our actual results may differ materially from those
indicated in the forward-looking statements. Therefore, you should
not rely on any of these forward-looking statements. Important
factors that could cause our actual results to differ materially
from those indicated in the forward-looking statements include,
among others, (i) our drug candidates and those of our
collaboration partners are in various stages of clinical
development and the risk of failure is high and can unexpectedly
occur at any stage prior to regulatory approval for numerous
reasons including safety and efficacy findings even after positive
findings in previous preclinical and clinical studies; (ii) the
timing of the commencement or end of clinical trials and the
commercial launch of drugs may be delayed or unsuccessful due to
regulatory delays, slower than anticipated patient enrollment,
manufacturing challenges, changing standards of care, evolving
regulatory requirements, clinical trial design, clinical outcomes,
competitive factors, or delay or failure in ultimately obtaining
regulatory approval in one or more important markets; (iii)
acceptance, review and approval decisions for new drug applications
by health authorities is an uncertain and evolving process and
health authorities retain significant discretion at all stages of
the regulatory review and approval decision process; (iv)
scientific discovery of new medical breakthroughs is an inherently
uncertain process and the future success of the application of our
technology platform to potential new drug candidates is therefore
highly uncertain and unpredictable and one or more research and
development programs could fail; (v) patents may not issue from our
patent applications for our drug candidates, patents that have
issued may not be enforceable, or additional intellectual property
licenses from third parties may be required; and (vii) the outcome
of any existing or future intellectual property or other litigation
related to our drug candidates and those of our collaboration
partners. Other important risks and uncertainties set forth
in our Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on November 7,
2014. Any forward-looking statement made by us in this press
release is based only on information currently available to us and
speaks only as of the date on which it is made. We undertake no
obligation to update any forward-looking statement, whether written
or oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise.
Contact:
Investors
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
Media
Nadia Hasan of WCG
212-257-6738
(1) Hyman, Steven E., Harvard Review of Psychiatry. 2(1):43-46,
May/June 1994.
i 2011 National Academy of Sciences. Relieving Pain
in America: A Blueprint for Transforming Prevention, Care,
Education and Research, 2010 Decision Resources, and Harstall, C.
How prevalent is chronic pain? Pain Clinical Updates X, 1-4
(2003).
ii
http://americanpainsociety.org/about-us/press-room/persistent-pain-incidence-news-release.
iii IMS, NSP, NPA and Defined Health 2013 Estimates.
iv Melnikova, I, Pain Market, Nature Reviews Drug
Discovery, Volume 9, 589-90 (August
2010).
v
http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html.
vi
http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html.
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