Topline Results from Phase 2 Clinical Trial of Oral NKTR-118 Presented at 20th American Academy of Pain Management Annual Clinical Meeting (AAPM) in Phoenix
PHOENIX and SAN CARLOS, Calif., Oct. 10 /PRNewswire-FirstCall/
-- Nektar Therapeutics (NASDAQ:NKTR) presented topline data today from
its Phase 2 clinical trial of oral NKTR-118 at the American Academy
of Pain Management's (AAPM) 20th Annual Clinical Meeting in
Phoenix, Arizona. NKTR-118, an oral peripherally-acting opioid
antagonist, is a late stage investigational product candidate in
clinical development for the treatment of opioid-induced
constipation. NKTR-118 was developed by Nektar, utilizing its
proprietary small molecule advanced polymer conjugate technology
platform.
Today's presentation at AAPM includes topline data previously
announced by the company in March 2009. In a Phase 2 double-blind,
randomized, placebo-controlled study of 208 patients with
opioid-induced constipation, NKTR-118 met the primary endpoint of
increase in spontaneous bowel movements over the baseline period.
There was no reversal or reduction of opioid-mediated analgesia in
any dose groups. NKTR-118 was also well tolerated with the most
commonly reported side effects being dose-dependent
gastrointestinal-related effects.
Download Today's Poster Presentation for NKTR-118
The poster presentation from today's AAPM 20th Annual Clinical
Meeting can be found on Nektar's website at http://www.nektar.com/product_pipeline/cns_pain_oral_nktr-118and119.html
AAPM Poster #39: "NKTR-118 Significantly Reverses Opioid-Induced
Constipation"
Complete Data from NKTR-118 Phase 2 Clinical Trial to be
presented in Oral Plenary Session at ACG 2009
Data from the Phase 2 clinical trial of NKTR-118 have been
accepted for presentation in an oral plenary session of the
American College of Gastroenterology (ACG) 2009 Annual Scientific
Meeting to be held in San Diego, California on October 27, 2009.
The data will be presented by Dr. Lynn Webster, medical director of
Lifetree Clinical Research and lead clinical investigator of the
Phase 2 trial.
On September 21, 2009, Nektar Therapeutics announced it had
entered into an exclusive worldwide license agreement with
AstraZeneca for its NKTR-118 and NKTR-119 programs.
About Opioid-Induced Constipation
The oral peripheral antagonist NKTR-118 targets mu-opioid
receptors within the enteric nervous system, which mediate
opioid-induced bowel dysfunction, a symptom complex resulting from
opioid use that encompasses symptoms such as constipation,
bloating, abdominal cramping, and gastroesophageal reflux.
Constipation is the hallmark of this syndrome and is generally its
most prominent component. In patients who take opiates chronically
for pain management, anywhere from 45-90% of patients will develop
debilitating constipation associated with other symptoms of
opioid-induced bowel dysfunction as a result of the drug binding to
the mu-opioid receptor in the gut(1).
According to IMS Health, about 230 million prescriptions were
written for opioids in 2007 in the United States alone. Currently,
there are no oral drugs approved that are indicated to treat
opioid-induced constipation (OIC). Opioid bowel dysfunction and OIC
can significantly impact quality of life and increase healthcare
utilization.
NKTR-119 is an investigational drug candidate that is a
co-formulation of oral NKTR-118 and an opioid analgesic. The
product is designed to provide good analgesic properties in the
chronic treatment of moderate to severe pain patients while
avoiding the debilitating side effects that are common with opioid
use, such as constipation and other symptoms of bowel
dysfunction.
About Nektar
Nektar Therapeutics is a biopharmaceutical company developing
novel therapeutics based on its PEGylation and advanced polymer
conjugation technology platforms. Nektar's technology and drug
development expertise have enabled nine approved products in the
U.S. or Europe for partners, which include leading
biopharmaceutical companies, including UCB's Cimzia® for
rheumatoid arthritis and Crohn's Disease, Roche's PEGASYS® for
hepatitis C and Amgen's Neulasta® for neutropenia. Nektar has
created a robust pipeline of potentially high-value therapeutics to
address unmet medical needs by leveraging and expanding its
technology platforms to improve and enable molecules. Nektar is
currently conducting clinical and preclinical programs in oncology,
pain and other therapeutic areas. NKTR-102, PEGylated irinotecan,
is currently in Phase 2 clinical studies in ovarian, breast and
colorectal cancer. NKTR-105, PEGylated docetaxel, is currently in a
Phase 1 clinical study in patients with refractory solid
tumors.
Nektar is headquartered in San Carlos, California, with
additional R&D 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/.
This press release contains forward-looking statements that
reflect the company's current views regarding the scientific and
commercial potential of NKTR-118, the results of the Phase 2 study
for that drug candidate and the potential of the company's product
development pipeline and technology platform. These forward-looking
statements involve risks and uncertainties, including but not
limited to: (i) NKTR-118 is in mid-stage clinical development and
the risk of failure remains high and failure can unexpectedly occur
at any stage prior to regulatory approval due to efficacy, safety
or other factors; (ii) the timing or success of the commencement or
end of clinical trials and commercial launch of new drugs may be
delayed or unsuccessful due to regulatory delays, clinical trial
design, slower than anticipated patient enrollment, drug
manufacturing challenges, changing standards of care, clinical
outcomes, or delay or failure in obtaining regulatory approval in
one or more important markets; (iii) the company's patent
applications for its proprietary or partner product candidates may
not issue, patents that have issued may not be enforceable, or
intellectual property licenses from third parties may be required
in the future; (iv) the outcome of any existing or future
intellectual property or other litigation related to the company's
proprietary product candidates; and (v) those risks and
uncertainties regarding the company's agreement with AstraZeneca
for the development and commercialization of NKTR-118 and NKTR-119
that are set forth in the company's Current Report on Form 8-K
filed with the Securities and Exchange Commission on September 21,
2009. Other important risks and uncertainties are detailed in the
company's reports and other filings with the Securities and
Exchange Commission, including its most recent Quarterly Report on
Form 10-Q and Annual Report on Form 10-K.
Actual results could differ materially from the forward-looking
statements contained in this press release. The company undertakes
no obligation to update forward-looking statements, whether as a
result of new information, future events or otherwise. For more
information on Nektar Therapeutics, please visit http://www.nektar.com/.
Contact: Jennifer Ruddock, 650-631-4954 Nektar Therapeutics
1. Panchal SJ, Muller-Schwefe P, Wurzelmann JI. Opioid-induced
bowel dysfunction: prevalence, pathophysiology and burden. Int J
Clin Pract. 2007;61(7):1181-1187.
Source: Nektar Therapeutics
CONTACT: Jennifer Ruddock for Nektar Therapeutics,
+1-650-631-4954
Web Site: http://www.nektar.com/
Posted: October 2009
