SAN
FRANCISCO, March 5, 2024 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR), a biotechnology company developing
medicines for the treatment of auto-immune disorders, today
announced the initiation of its Phase 2b clinical trial evaluating rezpegaldesleukin in
patients with severe to very severe alopecia areata.
Rezpegaldesleukin (REZPEG) is a novel agonistic T regulatory
cell biologic that is designed to both dampen the inflammatory
response and simultaneously restore immune balance by directly
expanding functional T reg cells and engaging multiple
immunoregulatory pathways.
"The start of this Phase 2b study
is another significant milestone for Nektar as we advance REZPEG, a
potentially transformative new mechanism for alopecia areata and
other auto-immune disorders," said Mary
Tagliaferri, M.D., Chief Medical Officer at Nektar
Therapeutics. "Alopecia areata is a disease where a patient's own
immune system attacks hair follicles and the resulting hair loss
can be devastating for patients. Current treatments available
have high relapse rates and carry potential safety challenges. As a
result, there is a high unmet need for durable and well-tolerated
treatment options that target the underlying dysfunction of the
immune system in these patients. We believe there's an opportunity
for REZPEG to emerge as a novel biologic mechanism for alopecia
patients and we look forward to our topline data from this study
expected in the first half of 2025."
Nektar's global, randomized, double-blind, placebo-controlled,
dose-ranging Phase 2b study will
investigate the efficacy and safety of REZPEG in 84 participants
with severe to very severe alopecia areata over a 36-week induction
treatment period. The induction treatment period will compare two
different dosing regimens of REZPEG against placebo. Participants
will be followed for an additional 24 weeks after the end of the
treatment period to evaluate durability. Initial results from the
study are anticipated in the first half of 2025.
The primary efficacy endpoint will evaluate mean percent
improvement in the Severity of Alopecia Tool (SALT) at week 36.
Secondary endpoints include proportion of participants with greater
than or equal to 50% reduction in SALT at week 36 and other
assessed timepoints and mean percent improvement in SALT at other
assessed timepoints.
About Alopecia Areata
The lifetime incidence of alopecia areata is 2% in both men and
women.1 Nearly 6.7 million people in the U.S. and 160
million worldwide develop alopecia areata in their lifetime. About
700,000 people in the U.S. currently have some form of alopecia
areata.2 It is often associated with other auto-immune
conditions as well as depression and anxiety.1 The
disease has a tremendous impact on quality of life for
patients.3 Available therapies for alopecia are not
durable and have high relapse rates and there is an urgent unmet
medical need for novel, more effective therapies for
patients.
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. In addition to this
clinical trial in patients with severe to very severe alopecia
areata, REZPEG is also being evaluated in a Phase 2b study in the treatment of adult patients with
moderate-to-severe atopic dermatitis (REZOLVE-AD; NCT06136741).
REZPEG is wholly-owned by Nektar Therapeutics.
About Nektar Therapeutics
Nektar Therapeutics is a biotechnology 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.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which
can be identified by words such as: "will," "expect," "develop,"
"potential," "advance," "anticipate," 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 Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on November 8, 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
- Lintzeri, D.A., Constantinou, A., Hillmann, K., Ghoreschi, K.,
Vogt, A. and Blume- Peytavi, U. (2022), Alopecia areata – Current
understanding and management. JDDG: Journal der Deutschen
Dermatologischen Gesellschaft, 20:
59-90. https://doi.org/10.1111/ddg.14689
- National Alopecia Areata Foundation
- Alhanshali L, Buontempo MG, Lo Sicco KI, Shapiro J. Alopecia
Areata: Burden of Disease, Approach to Treatment, and Current Unmet
Needs. Clin Cosmet Investig Dermatol.
2023;16:803-820
https://doi.org/10.2147/CCID.S376096
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