New Statistically Significant Results Reported for
Clinical Efficacy Endpoints of BSA, DLQI and POEM from Phase
1b Study
New Phase 2a Study Also Being Planned for
Rezpegaldesleukin in Alopecia Areata
SAN
FRANCISCO, Sept. 13, 2023 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today announced new data for
rezpegaldesleukin in patients with atopic dermatitis, including new
clinical efficacy endpoints from the Phase 1b study. Rezpegaldesleukin is Nektar's novel,
first-in-class selective regulatory T-cell (Treg) therapy, which is
being developed for the treatment of atopic dermatitis.
The company is presenting the new Phase 1b clinical efficacy endpoints for
rezpegaldesleukin at its investor and analyst event today. The new
data highlight rezpegaldesleukin's important promise to help
patients battling atopic dermatitis, a chronic skin condition that
afflicts nearly 10% of Americans.1 The company will also
present the trial designs for its Phase 2b study starting in October of rezpegaldesleukin
in atopic dermatitis and its new planned Phase 2a study starting in
early 2024 in alopecia areata.
"These new data announced today for rezpegaldesleukin in atopic
dermatitis demonstrate that, in addition to the strong previously
reported efficacy for EASI-related endpoints, rezpegaldesleukin has
the potential to be a differentiated therapeutic that could greatly
improve quality-of-life for patients," said Jonathan Zalevsky, Ph.D., Chief R&D Officer
of Nektar Therapeutics. "We look forward to advancing
rezpegaldesleukin into our robust Phase 2b study in biologic-naïve patients with moderate
to severe atopic dermatitis in October of this year. In
addition, we are excited to announce that we are also initiating a
Phase 2a study of rezpegaldesleukin in patients with alopecia
areata in early 2024."
The double-blind, randomized, placebo-controlled Phase
1b study of rezpegaldesleukin in
atopic dermatitis evaluated safety, tolerability, and
pharmacokinetics over a 12-week induction treatment period.
Patients with ≥EASI-50 response at Week 19 were followed for an
additional 36 weeks after the end of the treatment period or until
EASI-25 response criteria were no longer met. The first study
evaluated 44 patients with moderate-to-severe AtD who had
progressed on topical corticosteroids.
Highlights of final efficacy endpoints for the Phase
1b study in atopic
dermatitis:
TABLE 1:
Study
Arm
|
LS Mean %
improvement in EASI
score from baseline at
12 weeks
|
p-value
|
Placebo
|
47
|
-
|
12
µg/kg
|
65
|
NS
|
24
µg/kg
|
83
|
0.0020
|
|
EASI Improvement
results are least squares (LS) mean percent change from baseline
obtained from Mixed Model for Repeated Measures (MMRM) as specified
in the statistical analysis plan (SAP) defined in the protocol
(generated by independent statistical audit firm). P-value
confirmed by independent statistical audit.
|
TABLE 2:
Study
Arm
|
Proportion of
Patients Who
Achieved an EASI-75 Score at 12
weeks (NRI*
calculation)
|
Proportion of
Patients Who
Achieved an EASI-75 Score at 12
weeks (as
observed)
|
Placebo
|
20 %
|
29 %
|
12
µg/kg
|
25 %
|
33 %
|
24
µg/kg
|
41 %
|
58 %
|
|
*NRI: non-responder
imputation
|
TABLE 3:
Study
Arm
|
LS mean %
Improvement in
Affected Body Surface Area
from Baseline at 12 weeks
(BSA)
|
p-value
|
Placebo
|
36
|
-
|
12
µg/kg
|
55
|
NS
|
24
µg/kg
|
72
|
0.0158
|
|
BSA Improvement results
are least squares (LS) mean percent change from baseline obtained
from Mixed Model for Repeated Measures (MMRM) as specified in the
statistical analysis plan (SAP) defined in the protocol.
|
TABLE 4:
Study
Arm
|
LS mean %
Improvement in
Dermatology Life Quality
Index (DLQI) from baseline
at 12 weeks
|
p-value
|
Placebo
|
9
|
-
|
12
µg/kg
|
48
|
NS
|
24
µg/kg
|
78
|
0.0043
|
|
DLQI Improvement
results are least squares (LS) mean percent change from baseline
obtained from Mixed Model for Repeated Measures (MMRM) as specified
in the statistical analysis plan (SAP) defined in the
protocol.
|
TABLE 5:
Study
Arm
|
LS mean %
Improvement in
Patient-Oriented Eczema
Measure (POEM) from
baseline at 12 weeks
|
p-value
|
Placebo
|
15
|
-
|
12
µg/kg
|
44
|
NS
|
24
µg/kg
|
58
|
0.0100
|
|
POEM Improvement
results are least squares (LS) mean percent change from baseline
obtained from Mixed Model for Repeated Measures (MMRM) as specified
in the statistical analysis plan (SAP) defined in the
protocol.
|
Investor & Analyst Event
The company is hosting a virtual investor and analyst today
Wednesday, September 13, 2023 at
11:00 a.m. EST / 8:00 a.m. PST to discuss these final Phase
1b data of rezpegaldesleukin (REZPEG)
in patients with atopic dermatitis, the atopic dermatitis treatment
landscape and the potential role of rezpegaldesleukin, Nektar's
novel, first-in-class selective regulatory T-cell (Treg) therapy,
in the treatment of atopic dermatitis.
Invited speakers include:
- 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
- Dr. David Rosmarin, Chair of the
Department of Dermatology at Indiana
University and Kampen-Norins Scholar in Dermatology;
- Dr. Raj Chovatiya, Board Certified Dermatologist at
Northwestern University.
To access the conference call, please pre-register at Nektar
Call Registration. All registrants will receive dial-in information
and a PIN allowing them to access the live call.
Investors and analysts can also view slides and listen to the
live audio webcast of the presentation here. The event will also be
available for replay through October 13,
2023 on Nektar's website: www.nektar.com.
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly owned R&D pipeline of investigational medicines
in oncology and immunology as well as a portfolio of approved
partnered medicines. Nektar is headquartered in San Francisco, California, with additional
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.
Nektar 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," "plan" 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
- Eczema stats. National Eczema Association. (2023,
September 5).
https://nationaleczema.org/research/eczema-facts/
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SOURCE Nektar Therapeutics