– Phase 1b
Safety and Efficacy Data for Rezpegaldesleukin in Moderate to
Severe Atopic Dermatitis to be Presented in Late-Breaking Oral
Presentation –
SAN
FRANCISCO, Oct. 2, 2023 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ:NKTR) announced today that it will have two
presentations for rezpegaldesleukin (REZPEG), a first-in-class
selective regulatory T-cell (Treg) therapy, at the 2023 European
Academy of Dermatology and Venereology (EADV) Congress to be
held October 11-14 in Berlin. REZPEG is in Phase 2 development
for the treatment of atopic dermatitis and for the treatment of
alopecia areata.
"We are honored to be selected by EADV to present our
late-breaking Phase 1b data for
REZPEG and our Phase 2b study design
in patients with moderate to severe atopic dermatitis," said
Jonathan Zalevsky, Ph.D., Senior
Vice President and Chief Research & Development Officer at
Nektar. "The presentations highlight the momentum and strength of
our REZPEG program and, in particular, its potential as a remittive
therapy for patients with atopic dermatitis. We look forward to
advancing the program into our robust Phase 2b study in biologic-naïve patients with moderate
to severe atopic dermatitis later this month."
Details of the presentations at EADV are as follows:
Efficacy and Safety of Single Agent Rezpegaldesleukin, a
Selective Regulatory T-Cell-Inducing Interleukin-2 Conjugate, in
the Treatment of Atopic Dermatitis: Final Results from a Randomized
Phase 1b
Study (Abstract #6685, Session: DT301.3: Late
Breaking News. Friday, October 13,
14:30 – 14:45 CET)
Authors: Jonathan
Silverberg1, David
Rosmarin2, Raj Chovatiya3,
Stephen Schleicher4,
Leon Kircik5,6,
Timothy Rodgers7,
Sohail Chaudhry8,
Christie Fanton8,
Danni Yu8, Yi Liu8, Brian Kotzin8, Mary Tagliaferri8, Carsten Schmitz9, Ajay Nirula9, Jonathan Zalevsky8
Affiliations: 1Department Of Dermatology,
George Washington University School Of
Medicine, Washington, DC,
United States;
2Indiana University School of
Medicine, Indianapolis, IN,
United States;
3Feinberg School Of Medicine,
Northwestern University, Chicago,
IL, United States;
4DermDox Centers for Dermatology, Sugarloaf, PA, United States; 5Icans School of
Medicine at Mt. Sinai, New York,
NY, United States;
6Skin Sciences, PLLC, Louisville, KY, United States; 7Rodgers
Dermatology, Frisco, TX,
United States; 8Nektar
Therapeutics, San Francisco, CA,
United States; 9Eli
Lilly and Company, Indianapolis,
IN, United States.
A Phase 2b, Randomized,
Double-Blinded, Parallel-Group, Placebo-Controlled Study to
Evaluate the Efficacy and Safety of Rezpegaldesleukin in Adults
with Moderate-to-Severe Atopic Dermatitis (Abstract
#6218/ePoster #P0559. Trial in Progress)
Authors: Jonathan
Silverberg1, Raj Chovatiya2,
David Rosmarin3,
Lisa Beck4, Melinda Gooderham5, Andrew Blauvelt6, Stephen Schleicher7, Sohail Chaudhry8, Christie Fanton8, Danni Yu8, Yi
Liu8, Zachary
Lee8, Mario
Marcondes8, Brian
Kotzin8, Mary
Tagliaferri8, Jonathan
Zalevsky8, Thomas
Bieber9
Affiliations: 1Department Of Dermatology,
George Washington University School Of
Medicine, Washington, DC,
United States;
2Feinberg School Of Medicine,
Northwestern University, Chicago,
IL, United States;
3Indiana University School of
Medicine, Indianapolis, IN,
United States;
4University Of Rochester Medical Center, Rochester, NY, United States; 5Department of
Medicine, Queen's University, Kingston,
ON, Canada;
6Oregon Medical Research Center, Portland, United
States; 7DermDox Centers for Dermatology,
Sugarloaf, PA, United States; 8Nektar
Therapeutics, San Francisco, CA,
United States;
9Christine Kühne Center For Allergy Research And
Education, University Of Bonn, Bonn, Germany
2023 EADV presentations will be available for download after
each session http://www.nektar.com/science/scientific-posters.
About REZPEG
Autoimmune and inflammatory diseases cause the immune system to
mistakenly attack and damage healthy cells in a person's body. A
failure of the body's self-tolerance mechanisms enables the
formation of the pathogenic T lymphocytes that conduct this attack.
REZPEG is a potential first-in-class resolution therapeutic that
may address this underlying immune system imbalance in people with
many autoimmune and inflammatory conditions. It targets the
interleukin-2 receptor complex in the body in order to stimulate
proliferation of powerful inhibitory immune cells known as
regulatory T cells. By activating these cells, REZPEG may act to
bring the immune system back into balance.
REZPEG is being developed as a self-administered injection for a
number of autoimmune and inflammatory diseases. It is wholly-owned
by Nektar Therapeutics.
About Nektar
Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly owned R&D pipeline of investigational medicines
in immunology and oncology as well as a portfolio of approved
partnered medicines. Nektar is headquartered in San Francisco, California, with additional
manufacturing operations in Huntsville,
Alabama. Further information about the company and its drug
development programs and capabilities may be found online at
http://www.nektar.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can
be identified by words such as: "will," "could," "develop,"
"potential," "advance" and similar references to future periods.
Examples of forward-looking statements include, among others,
statements regarding the therapeutic potential of, and future
development plans for, rezpegaldesleukin. 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 statements regarding the therapeutic potential of
rezpegaldesleukin are based on preclinical and clinical findings
and observations and are subject to change as research and
development continue; (ii) rezpegaldesleukin is an investigational
agent and continued research and development for this drug
candidate is subject to substantial risks, including negative
safety and efficacy findings in future clinical studies
(notwithstanding positive findings in earlier preclinical and
clinical studies); (iii) rezpegaldesleukin is in clinical
development and the risk of failure is high and can unexpectedly
occur at any stage prior to regulatory approval; (iv) the timing of
the commencement or end of clinical trials and the availability of
clinical data may be delayed or unsuccessful due to challenges
caused by the COVID-19 pandemic, 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; (v) we may not achieve the expected cost savings
we expect from our 2022 corporate restructuring and reorganization
plan or our 2023 cost restructuring plan and we may undertake
additional restructuring and cost-saving activities in the future,
(vi) 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) certain other important risks and
uncertainties set forth in our Annual Report on Form 10-Q filed
with the Securities and Exchange Commission on August 9, 2023. 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:
For Investors:
Vivian Wu of Nektar Therapeutics
628-895-0661
For Media:
David Rosen of Argot Partners
212-600-1902
david.rosen@argotpartners.com
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