Company plans to move REZPEG forward into Phase 2 clinical study in atopic dermatitis
As announced in a press release issued on
Phase 1b data for REZPEG in atopic dermatitis were presented at an investment presentation made by Eli Lilly and Company in
"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 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
"We are pleased to be regaining full rights to REZPEG," said
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
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
1. Weidinger S, Novak N.
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.
Vivian Wu of Nektar Therapeutics
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