Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis
Nektar Therapeutics (NKTR) has received FDA Fast Track designation for rezpegaldesleukin, a treatment for moderate-to-severe atopic dermatitis in patients 12 years and older whose condition isn't adequately controlled by topical prescriptions. The investigational biologic therapy targets the interleukin-2 receptor complex to stimulate regulatory T cells.
Clinical data has shown rapid improvement in disease outcomes during a 12-week induction treatment phase, with benefits lasting at least 36 weeks post-treatment. The company expects to announce topline data from their Phase 2b REZOLVE-AD study in Q2 2025.
The Fast Track designation enables more frequent FDA interactions and potential eligibility for rolling review and priority review, aimed at accelerating the development process for treatments addressing serious conditions with unmet medical needs.
Nektar Therapeutics (NKTR) ha ricevuto la designazione Fast Track dalla FDA per rezpegaldesleukin, un trattamento per la dermatite atopica da moderata a grave in pazienti di 12 anni e oltre la cui condizione non è adeguatamente controllata da prescrizioni topiche. Questa terapia biologica sperimentale colpisce il complesso del recettore dell'interleuchina-2 per stimolare le cellule T regolatorie.
I dati clinici hanno mostrato un rapido miglioramento nei risultati della malattia durante una fase di trattamento di induzione di 12 settimane, con benefici che durano almeno 36 settimane dopo il trattamento. L'azienda prevede di annunciare i dati preliminari del loro studio Phase 2b REZOLVE-AD nel secondo trimestre del 2025.
La designazione Fast Track consente interazioni più frequenti con la FDA e potrebbe portare a una revisione continua e a una revisione prioritaria, con l'obiettivo di accelerare il processo di sviluppo per trattamenti che affrontano condizioni gravi con bisogni medici non soddisfatti.
Nektar Therapeutics (NKTR) ha recibido la designación de Vía Rápida de la FDA para rezpegaldesleukin, un tratamiento para la dermatitis atópica de moderada a grave en pacientes de 12 años y más cuyas condiciones no están suficientemente controladas por recetas tópicas. Esta terapia biológica en investigación se dirige al complejo del receptor de interleucina-2 para estimular las células T regulatorias.
Los datos clínicos han mostrado una mejora rápida en los resultados de la enfermedad durante una fase de tratamiento de inducción de 12 semanas, con beneficios que duran al menos 36 semanas después del tratamiento. La compañía espera anunciar los datos preliminares de su estudio de fase 2b REZOLVE-AD en el segundo trimestre de 2025.
La designación de Vía Rápida permite interacciones más frecuentes con la FDA y la posible elegibilidad para una revisión continua y una revisión prioritaria, con el objetivo de acelerar el proceso de desarrollo de tratamientos para condiciones graves con necesidades médicas no satisfechas.
넥타 Therapeutics (NKTR)는 12세 이상의 보통에서 중증 아토피 피부염 치료제인 레즈페갈데슬루킨에 대해 FDA의 빠른 진전 지정을 받았습니다. 이 실험적인 생물학적 치료법은 인터루킨-2 수용체 복합체를 목표로 하여 조절 T 세포를 자극합니다.
임상 데이터는 12주 유도 치료 기간 동안 질병 결과의 빠른 개선을 보여주었고, 치료 후 최소 36주 동안 혜택이 지속되었습니다. 이 회사는 2025년 2분기에 Phase 2b REZOLVE-AD 연구의 주요 데이터를 발표할 것으로 기대하고 있습니다.
빠른 진전 지정을 통해 FDA와의 상호작용이 더 자주 이루어지고, 연속 검토 및 우선 검토의 적격성이 있을 수 있으며, 이는 치료 개발 과정을 가속화하는 것을 목표로 합니다.
Nektar Therapeutics (NKTR) a reçu la désignation Fast Track de la FDA pour rezpegaldesleukin, un traitement pour la dermatite atopique modérée à sévère chez les patients âgés de 12 ans et plus dont l'état n'est pas suffisamment contrôlé par des prescriptions topiques. Cette thérapie biologique expérimentale cible le complexe du récepteur de l'interleukine-2 pour stimuler les cellules T régulatrices.
Les données cliniques ont montré une amélioration rapide des résultats de la maladie pendant une phase de traitement d'induction de 12 semaines, avec des bénéfices qui durent au moins 36 semaines après le traitement. La société s'attend à annoncer les données préliminaires de leur étude Phase 2b REZOLVE-AD au deuxième trimestre de 2025.
La désignation Fast Track permet des interactions plus fréquentes avec la FDA et une éventuelle éligibilité à une révision continue et à une révision prioritaire, visant à accélérer le processus de développement pour les traitements répondant à des conditions graves avec des besoins médicaux insatisfaits.
Nektar Therapeutics (NKTR) hat von der FDA die Fast-Track-Designierung für rezpegaldesleukin erhalten, eine Behandlung für mäßige bis schwere atopische Dermatitis bei Patienten ab 12 Jahren, deren Zustand nicht ausreichend durch topische Verschreibungen kontrolliert werden kann. Die experimentelle biologische Therapie zielt auf den Interleukin-2-Rezeptorkomplex ab, um regulatorische T-Zellen zu stimulieren.
Klinische Daten haben während einer 12-wöchigen Induktionsbehandlungsphase eine schnelle Verbesserung der Krankheitsverläufe gezeigt, wobei die Vorteile mindestens 36 Wochen nach der Behandlung anhalten. Das Unternehmen erwartet, die vorläufigen Daten aus ihrer Phase-2b-Studie REZOLVE-AD im 2. Quartal 2025 bekannt zu geben.
Die Fast-Track-Designierung ermöglicht häufigere Interaktionen mit der FDA und eine potenzielle Eignung für ein rollendes und prioritäres Review, das darauf abzielt, den Entwicklungsprozess für Behandlungen zu beschleunigen, die ernste Erkrankungen mit ungedeckten medizinischen Bedürfnissen adressieren.
- Received FDA Fast Track designation for rezpegaldesleukin
- Demonstrated positive clinical results with 36-week post-treatment benefits
- Phase 2b study results expected in Q2 2025
- Eligible for expedited development and review process
- None.
Insights
The FDA's Fast Track designation for rezpegaldesleukin marks a important inflection point for Nektar Therapeutics in the $14 billion global atopic dermatitis market. The designation's significance extends beyond mere regulatory acceleration - it validates the drug's novel approach in a highly competitive landscape dominated by JAK inhibitors and biologics like Dupixent.
The drug's mechanism of action targeting regulatory T cells (Tregs) represents a paradigm shift in atopic dermatitis treatment. Most notably, the demonstrated 36-week efficacy persistence after treatment cessation could be a game-changing differentiator, potentially reducing treatment burden and improving compliance compared to current therapies requiring continuous administration.
From a development perspective, the Fast Track designation offers three critical advantages: 1) More frequent FDA interactions to optimize the development strategy, 2) Potential eligibility for rolling review, which could expedite the final approval process and 3) Possible priority review qualification, potentially reducing the standard review period from 10 to 6 months.
The upcoming Phase 2b REZOLVE-AD topline data in Q2 2025 will be pivotal. If positive, the Fast Track status could accelerate the path to market by 6-12 months, potentially enabling market entry by 2027-2028. For Nektar, success in atopic dermatitis could unlock additional autoimmune indications, significantly expanding the drug's commercial potential.
In patients with moderate-to-severe atopic dermatitis, rezpegaldesleukin has been shown to rapidly improve measurable exploratory disease outcomes during a 12-week induction treatment phase and 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 that rezpegaldesleukin has been designated a Fast Track product," said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Research & Development Officer at Nektar. "Rezpegaldesleukin has the potential to address a significant unmet need for the millions of patients living with moderate-to-severe atopic dermatitis. We remain on track to announce topline data from the induction period of our Phase 2b REZOLVE-AD study in the second quarter of this year. This designation will now allow us to collaborate closely with the agency on the design of the registrational program for rezpegaldesleukin once we've completed Phase 2."
The goal of the FDA's Fast Track process is to ensure that important new treatments reach patients as quickly as possible. The designation is granted to investigational therapies that treat serious conditions and have the potential to address an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate's development plan as well as possible eligibility for rolling review and priority review.
About REZOLVE-AD
The REZOLVE-AD (NCT06136741) study enrolled 398 patients with moderate-to-severe atopic dermatitis who had not previously received treatment with biologic or JAK inhibitor therapies. Patients randomized across three different dose regimens of rezpegaldesleukin and 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:
Enrollment criteria in the study included a minimum EASI score of 16.0, a minimum Body Surface Area (BSA) of
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
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
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "will," "announce," "potential," "may," "allow," "can," and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the potential benefits from Fast Track designation, the therapeutic potential of, and future development plans for, rezpegaldesleukin, and the timing for the announcement of rezpegaldesleukin clinical data. 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) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in
For Investors:
Vivian Wu of Nektar Therapeutics
628-895-0661
For Media:
Madelin Hawtin
LifeSci Communications
603-714-2638
mhawtin@lifescicomms.com
1. | Silverberg, J.I., Rosmarin, D., Chovatiya, R. et al. The regulatory T cell-selective interleukin-2 receptor |
2. | Hanifin, J. M., Reed, M. L. & Eczema Prevalence and Impact Working Group. A population-based survey of |
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SOURCE Nektar Therapeutics
FAQ
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