Company plans to move REZPEG forward into
Phase 2 clinical study in atopic dermatitis
SAN
FRANCISCO, April 27, 2023 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today announced that it will be
regaining the full rights to REZPEG from Eli Lilly and Company.
As announced in a press release issued on April 17, Nektar plans to move forward with
REZPEG and will initiate a Phase 2b
study in patients with moderate-to-severe atopic dermatitis in
2023. The company will also explore other auto-immune indications
for the development plan for REZPEG.
Phase 1b data for REZPEG in atopic
dermatitis were presented at an investment presentation made by Eli
Lilly and Company in December 2021
and at the 2022 European Academy of Dermatology (EADV). REZPEG
evidenced a dose-dependent improvement over placebo for key
efficacy measures of mean change in EASI, EASI-75, vIGA-AD scores,
and Itch NRS ≥4-point scales. These improvements were observed for
an additional 36 weeks following the 12-week treatment period.
"The promising Phase 1b data
presented at the 2022 EADV conference warrant moving REZPEG forward
into Phase 2 development," said Jonathan Silverberg, MD, PhD,
MPH, Associate Professor of Dermatology at The George Washington University School of Medicine and Health
Sciences in Washington, DC
and the Director of Clinical Research and Contact Dermatitis. "The
durability of the response may offer an opportunity for a quarterly
maintenance dosing regimen and improved long-term disease
control."
The proof-of-concept data presented to-date on REZPEG also
evidenced REZPEG's ability to stimulate Tregs to target an immune
system imbalance resulting in an improvement of disease activity in
patients. In addition, REZPEG data were recently highlighted in a
talk by Eric Lawrence Simpson, MD,
FAAD at the 2023 American Academy of Dermatology (AAD) Annual
Meeting on March 17, 2023 in the
scientific session covering atopic dermatitis, as a potential
future remittive therapy.
"We are pleased to be regaining full rights to REZPEG," said
Howard W. Robin, President and CEO
of Nektar. "We plan to work quickly to initiate a Phase
2b study in atopic dermatitis. We
believe the strong data generated to-date for REZPEG in atopic
dermatitis show the significant potential for REZPEG to emerge as
an innovative new mechanism with the possibility of disease
resolution in a growing biologic treatment field. We are excited
about REZPEG's immune-modulatory profile and believe it could offer
great hope in the future to patients who are managing this common
and debilitating condition. We look forward to demonstrating this
in the clinic as quickly as possible."
About Nektar Therapeutics
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.
About Rezpegaldesleukin (REZPEG, NKTR-358)
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 an investigational, potential first-in-class T regulatory
cell stimulator that may address this underlying immune system
imbalance in people with many autoimmune and inflammatory
conditions. It is designed to target 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.
About Atopic Dermatitis
Atopic dermatitis is a chronic skin disease characterized by
intense itching, dry skin and inflammation that can be present on
any part of the body.1 Atopic dermatitis is a
heterogeneous disease and may be characterized by a highly variable
appearance in which flares occur in an unpredictable
manner.2 It is estimated that 16.5 million U.S. adults
are affected by the disease with nearly 40% being diagnosed with
moderate to severe disease.3
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can
be identified by words such as: "will," "may," "advance,"
"support," "develop," "provide," "expect," "aim," "potential" 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, and our other drug candidates in research
programs, the prospects and plans for our collaborations with other
companies, the timing of the initiation of clinical studies and the
data readouts for our drug candidates. 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, and our other drug
candidates are based on preclinical and clinical findings and
observations and are subject to change as research and development
continue; (ii) rezpegaldesleukin and our other drug candidates are
investigational agents and continued research and development for
these drug candidates is subject to substantial risks, including
negative safety and efficacy findings in ongoing clinical studies
(notwithstanding positive findings in earlier preclinical and
clinical studies); (iii) rezpegaldesleukin and our other drug
candidates 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; (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-K filed with the
Securities and Exchange Commission on February 28, 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.
1. Weidinger S, Novak N. Lancet.
2016;387:1109-1122.
2. Langan SM, et al.
Arch Dermatol.
2008;142:1109.
3. Chiesa
Fuxench, Z. C. et
al. J. Invest. Dermatol.
2019;139(3): 583-590.
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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