SAN
FRANCISCO, Jan. 10, 2025 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today announced the company has
completed target enrollment in its REZOLVE-AD Phase 2b study of rezpegaldesleukin in patients with
moderate-to-severe atopic dermatitis.
Rezpegaldesleukin is a first-in-class interleukin-2 receptor
(IL-2R) agonist that proliferates and activates regulatory T cells
(Tregs) with promising dose-dependent clinical activity in multiple
skin disease settings. Results from multiple clinical trials showed
that rezpegaldesleukin safely and dose-dependently increased Tregs
and rapidly improved measurable exploratory disease outcomes in
patients with moderate-to-severe atopic dermatitis that were
largely durable for at least 36 weeks after ceasing treatment,
demonstrating proof-of-concept in this indication.1
Proof-of-concept efficacy and safety data from a Phase 1b study of rezpegaldesleukin in atopic
dermatitis patients were presented at the 2023 EADV Congress in
October 2023 (Presentation Link).
"We are pleased to announce that we reached our target
enrollment for our 396-patient Phase 2b trial of rezpegaldesleukin," said Howard W. Robin, President and CEO of Nektar
Therapeutics. "We are grateful to the patients and physicians whose
strong interest in this novel mechanism, together with the
proof-of-concept clinical data, led to completing enrollment of the
study in just 14 months. Less than 10% of the 30 million atopic
dermatitis patients who can receive biologics in the US and
Europe are currently receiving
treatment and we believe that novel mechanisms are key to helping
more patients with this chronic and serious skin disorder. We look
forward to announcing the topline data from the 16-week induction
treatment period in this study in the second quarter of 2025."
The REZOLVE-AD (NCT06136741) study enrolled patients with
moderate-to-severe atopic dermatitis who had not previously
received treatment with biologic or JAK inhibitor therapies.
Patients were randomized across three different dose regimens
of rezpegaldesleukin or placebo for a 16-week induction
treatment period. Following this period, patients who meet an
Eczema Area and Severity Index (EASI) score threshold for
advancement to maintenance are re-randomized to one of two
maintenance regimens at their original dose level to receive
maintenance therapy either once a month or once every three
months.
The primary endpoint of the Phase 2b study is mean improvement in EASI score at the
end of the 16-week induction treatment period. Secondary endpoints
include the proportion of patients achieving Validated Investigator
Global Assessment (vIGA-AD) of 0 or 1, those achieving EASI-75, and
those achieving a greater than or equal to a 4-point improvement in
Itch Numeric Rating Scale (NRS).
This trial was initiated in October
2023. Patients were enrolled across approximately 110 sites
globally with: 67% enrolled in the European countries of
Poland, Bulgaria, Germany, Czechia, Spain, Croatia and Hungary; 17% enrolled in the United States; 11% enrolled in
Canada; and 5% enrolled in
Australia. Patient randomization
was stratified based on baseline disease severity measured by
vIGA-AD and geographic region.
Enrollment criteria in the study included a minimum EASI score
of 16.0, a minimum Body Surface Area (BSA) of 10% and a minimum
vIGA-AD of 3 at both screening and randomization. Patients who
experienced an unstable course of atopic dermatitis between
screening and randomization per investigator assessment were
excluded from the study.
About Rezpegaldesleukin
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.
Rezpegaldesleukin 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, rezpegaldesleukin may act to bring the immune system back
into balance.
Rezpegaldesleukin is being developed as a self-administered
injection for a number of autoimmune and inflammatory diseases. In
addition to the REZOLVE-AD study, it is also being evaluated in the
REZOLVE-AA study, a randomized, double blind, placebo-controlled
Phase 2b clinical trial for treatment
of patients with severe-to-very-severe alopecia areata
(NCT06340360). Rezpegaldesleukin is wholly-owned by Nektar
Therapeutics.
About Atopic Dermatitis
Atopic Dermatitis is the most common type of eczema, affecting
approximately 30 million people in the
United States.2 AD is characterized by a defect
in the skin barrier, which allows allergens and other irritants to
enter the skin, leading to an immune reaction and inflammation.
About Nektar Therapeutics
Nektar Therapeutics is a clinical-stage biotechnology company
focused on developing treatments that address the underlying
immunological dysfunction in autoimmune and chronic inflammatory
diseases. Nektar's lead product candidate, rezpegaldesleukin
(REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell
stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and
one in alopecia areata. Nektar's pipeline also includes a
preclinical bivalent tumor necrosis factor receptor type II (TNFR2)
antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a
modified hematopoietic colony stimulating factor (CSF) protein,
NKTR-422. Nektar, together with various partners, is also
evaluating NKTR-255, an investigational IL-15 receptor agonist
designed to boost the immune system's natural ability to fight
cancer, in several ongoing clinical trials. Nektar is headquartered
in San Francisco, California. For
further information, visit www.nektar.com and follow Nektar on
LinkedIn.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which can
be identified by words such as: "will," "announce," "potential,"
"advance," "anticipate," "can," 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 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) 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 (vi)
certain other important risks and uncertainties set forth in our
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on November 8, 2024. 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.
For Investors:
Vivian Wu of Nektar
Therapeutics
628-895-0661
For Media:
Madelin Hawtin
LifeSci Communications
603-714-2638
mhawtin@lifescicomms.com
- Silverberg, J.I., Rosmarin, D., Chovatiya, R. et
al. The regulatory T cell-selective interleukin-2 receptor
agonist rezpegaldesleukin in the treatment of inflammatory skin
diseases: two randomized, double-blind, placebo-controlled phase
1b trials. Nat Commun 15, 9230 (2024).
https://doi.org/10.1038/s41467-024-53384-1
- Hanifin, J. M., Reed, M. L. & Eczema Prevalence and Impact
Working Group. A population-based survey of eczema prevalence in
the United States.
Dermatitis 18, 82–91 (2007).
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