– Dose-Dependent Efficacy Reported Across All
Endpoints for REZPEG Demonstrating a Rapid Onset of Action and
Continuing Benefit for 36 Weeks After 12-Week Treatment Period
–
– New Data Presented Show Encouraging Proportion
of Patient-Reported Responder Outcomes for DLQI and POEM Endpoints
–
SAN
FRANCISCO, Oct. 13, 2023 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ:NKTR) today announced new data for
rezpegaldesleukin (REZPEG), a first-in-class selective regulatory
T-cell (Treg) therapy, in patients with atopic dermatitis (AD) at
the 2023 European Academy of Dermatology and Venereology (EADV)
Congress. These data were presented by Dr. Jonathan Silverberg, Professor of Dermatology at
The George Washington University School of
Medicine and Health Sciences and Director of Clinical
Research and Contact Dermatitis in a late-breaking oral
presentation.
"Data from this presentation demonstrate consistent benefit with
REZPEG across multiple clinician and patient-reported outcomes,
which were maintained through 36 weeks after treatment ended," said
Dr. Jonathan Silverberg. "The
sustained post-treatment benefit observed with REZPEG has the
potential to alter the need for frequent maintenance dosing for
patients with atopic dermatitis. Together with the observed safety
profile, these promising results potentially open the door for a
new therapeutic class."
In the Phase 1b study, patients
with moderate-to-severe AD that were treated with REZPEG showed
dose-dependent improvements in Eczema Area and Severity Index
(EASI), Validated Investigator Global Assessment (vIGA), Body
Surface Area (BSA), and Itch Numeric Rating Scale (NRS) over 12
weeks of treatment compared to placebo, which were sustained
post-treatment over an additional 36 weeks. At the highest studied
dose, the proportion of Daily Life Quality Index (DLQI) responders
was 75% and the proportion of Patient Oriented Eczema Measure
(POEM) responders was 65% at week 12. The proportion of responders
were generally sustained after treatment ended through the 36-week
follow-up. This durability highlights REZPEG's disease remittive
potential.
REZPEG was well tolerated with no patients in the REZPEG groups
experiencing severe, serious, or fatal adverse events, and no
anti-REZPEG antibodies were detected. Pharmacodynamic data observed
in the Phase 1b study corroborate the
clinical efficacy signal observed in patients. Compared with
placebo, there were sustained increases in absolute numbers of
circulating total (FoxP3+CD25+) and
CD25bright Tregs in the REZPEG treatment arms. The peak
increase in CD25bright Treg number was 10-fold above
baseline in the 24 µg/kg group.
Based on these data, the company is initiating two Phase 2
studies in atopic dermatitis and in alopecia areata. These trials
are expected to initiate in October of this year and in early 2024,
respectively. The trial design for the study in patients with
moderate-to-severe atopic dermatitis was presented in an ePoster at
EADV earlier this week.
"The findings presented today confirm our previously-reported
data demonstrating the efficacy and rapid onset of action of REZPEG
and continue to reinforce the promise of REZPEG as a novel
therapeutic for patients with moderate-to-severe atopic
dermatitis," said Jonathan Zalevsky,
Ph.D., Senior Vice President and Chief Research & Development
Officer at Nektar. "We look forward to advancing the program into
our robust Phase 2b study in this
indication and exploring its therapeutic potential in other
autoimmune indications, including alopecia areata."
Highlight of the new patient-reported outcomes for the
Phase 1b study in atopic dermatitis
presented at EADV 2023 for the first time:
Proportion of
Patients Who Achieved a DLQI Greater than or Equal
to a 4-point Reduction from Baseline (NRI*
calculation)
|
Study
Arm
|
12
weeks
|
48
weeks
|
Placebo
|
30 %
|
33 %
|
12 μg/kg
|
46 %
|
25 %
|
24 μg/kg
|
75%
(p = 0.0426)
|
56 %
|
*NRI: non-responder
imputation
|
Proportion of
Patients Who Achieved a POEM Greater than or Equal to a 4-point
Reduction from Baseline (NRI* calculation)
|
Study
Arm
|
12
weeks
|
48
weeks
|
Placebo
|
30 %
|
33 %
|
12 μg/kg
|
50 %
|
22 %
|
24 μg/kg
|
65 %
|
70 %
|
*NRI: non-responder
imputation
|
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)
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)
2023 EADV presentations are available for download at
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," "expect," "initiate" 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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