Nektar Therapeutics Announces Completion of Target Enrollment in REZOLVE-AD Phase 2b Clinical Trial of Rezpegaldesleukin in Patients with Moderate-to-Severe Atopic Dermatitis
Nektar Therapeutics (NKTR) has completed target enrollment in its REZOLVE-AD Phase 2b study of rezpegaldesleukin for moderate-to-severe atopic dermatitis. The 396-patient trial, initiated in October 2023, reached full enrollment in just 14 months across approximately 110 global sites.
The study focuses on patients who haven't previously received biologic or JAK inhibitor therapies. Participants are randomized across three dose regimens or placebo for a 16-week induction treatment period. The primary endpoint measures improvement in EASI score, with secondary endpoints including vIGA-AD, EASI-75, and Itch NRS improvements.
Geographic distribution of enrollment includes: 67% in European countries, 17% in the United States, 11% in Canada, and 5% in Australia. Previous clinical trials demonstrated that rezpegaldesleukin safely increased Tregs and improved disease outcomes, with effects lasting up to 36 weeks post-treatment.
Nektar Therapeutics (NKTR) ha completato il reclutamento previsto nel suo studio REZOLVE-AD di Fase 2b su rezpegaldesleukin per la dermatite atopica moderata-severa. Lo studio, che coinvolge 396 pazienti, è stato avviato nell'ottobre 2023 e ha raggiunto il reclutamento completo in soli 14 mesi, distribuito su circa 110 siti globali.
La ricerca si concentra su pazienti che non hanno precedentemente ricevuto trattamenti biologici o inibitori JAK. I partecipanti sono stati randomizzati su tre regimi di dosaggio o placebo per un periodo di trattamento di induzione di 16 settimane. L'obiettivo primario misura il miglioramento del punteggio EASI, mentre gli obiettivi secondari includono miglioramenti nel vIGA-AD, EASI-75 e NRS prurito.
La distribuzione geografica del reclutamento include: 67% nei paesi europei, 17% negli Stati Uniti, 11% in Canada e 5% in Australia. Studi clinici precedenti hanno dimostrato che rezpegaldesleukin aumenta in modo sicuro i Tregs e migliora gli esiti della malattia, con effetti che durano fino a 36 settimane dopo il trattamento.
Nektar Therapeutics (NKTR) ha completado el reclutamiento objetivo en su estudio REZOLVE-AD de Fase 2b sobre rezpegaldesleukin para la dermatitis atópica moderada a severa. El ensayo, que abarca a 396 pacientes, se inició en octubre de 2023 y alcanzó el reclutamiento completo en solo 14 meses, en aproximadamente 110 sitios globales.
El estudio se enfoca en pacientes que no han recibido previamente terapias biológicas o inhibidores de JAK. Los participantes se aleatorizan en tres regímenes de dosis o placebo para un período de tratamiento de inducción de 16 semanas. El objetivo primario mide la mejora en la puntuación de EASI, mientras que los objetivos secundarios incluyen mejoras en vIGA-AD, EASI-75 y NRS de picor.
La distribución geográfica del reclutamiento incluye: 67% en países europeos, 17% en Estados Unidos, 11% en Canadá y 5% en Australia. Ensayos clínicos anteriores demostraron que rezpegaldesleukin aumentó de manera segura los Tregs y mejoró los resultados de la enfermedad, con efectos que duran hasta 36 semanas después del tratamiento.
넥타 Therapeutics (NKTR)는 중등도에서 중증 아토피 피부염에 대한 레즈페갈데슬루킨의 REZOLVE-AD 2b 단계 연구에서 목표 환자 수를 완료했습니다. 396명의 환자를 포함하는 이 임상 시험은 2023년 10월에 시작되어 약 110개의 글로벌 사이트에서 단 14개월 만에 전체 등록을 완료했습니다.
이번 연구는 이전에 생물학적 치료나 JAK 억제제 치료를 받지 않은 환자들을 대상으로 하고 있습니다. 참가자들은 16주 간의 유도 치료 기간 동안 3개의 용량 요법 또는 위약에 무작위로 배정됩니다. 주요 평가 기준은 EASI 점수의 개선이며, 이차 평가 기준에는 vIGA-AD, EASI-75 및 가려움증 NRS 개선이 포함됩니다.
등록의 지리적 분포는 다음과 같습니다: 유럽 국가 67%, 미국 17%, 캐나다 11%, 호주 5%. 이전의 임상 시험에서는 레즈페갈데슬루킨이 안전하게 Tregs를 증가시키고 질병 경과를 개선했으며, 치료 후 최대 36주 동안 효과가 지속되었음을 보여주었습니다.
Nektar Therapeutics (NKTR) a achevé le recrutement des cibles dans son étude REZOLVE-AD de phase 2b sur le rezpegaldesleukin pour la dermatite atopique modérée à sévère. L'essai, comprenant 396 patients, a été lancé en octobre 2023 et a atteint un recrutement complet en seulement 14 mois à travers environ 110 sites mondiaux.
L'étude se concentre sur les patients qui n'ont pas encore reçu de thérapies biologiques ou d'inhibiteurs de JAK. Les participants sont randomisés selon trois régimes de dose ou placebo pour une période de traitement d'induction de 16 semaines. Le critère principal évalue l'amélioration du score EASI, tandis que les critères secondaires incluent des améliorations des scores vIGA-AD, EASI-75 et NRS de démangeaison.
La répartition géographique des recrutements est la suivante : 67 % dans des pays européens, 17 % aux États-Unis, 11 % au Canada et 5 % en Australie. Des essais cliniques précédents ont montré que le rezpegaldesleukin augmentait en toute sécurité les Tregs et améliorait les résultats de la maladie, avec des effets perdurant jusqu'à 36 semaines après le traitement.
Nektar Therapeutics (NKTR) hat die Zielrekrutierung in seiner REZOLVE-AD Phase 2b Studie zu Rezpegaldesleukin bei moderater bis schwerer atopischer Dermatitis abgeschlossen. Die Studie mit 396 Patienten, die im Oktober 2023 begonnen wurde, erreichte in nur 14 Monaten die vollständige Rekrutierung an etwa 110 globalen Standorten.
Die Studie konzentriert sich auf Patienten, die zuvor keine biologischen Therapien oder JAK-Inhibitoren erhalten haben. Die Teilnehmer werden randomisiert in drei Dosierungsregimen oder Placebo für einen 16-wöchigen Induktionsbehandlungszeitraum. Der primäre Endpunkt misst die Verbesserung des EASI-Scores, während sekundäre Endpunkte Verbesserungen bei vIGA-AD, EASI-75 und Juckreiz-NRS umfassen.
Die geografische Verteilung der Rekrutierung umfasst: 67 % in europäischen Ländern, 17 % in den Vereinigten Staaten, 11 % in Kanada und 5 % in Australien. Frühere klinische Studien haben gezeigt, dass Rezpegaldesleukin sicher Tregs erhöht und die Krankheitsverläufe verbessert hat, wobei die Wirkungen bis zu 36 Wochen nach der Behandlung anhalten.
- Completed enrollment target of 396 patients ahead of schedule in 14 months
- Strong patient and physician interest in the trial
- Previous trials showed promising durability of treatment effects up to 36 weeks
- Large market potential with less than 10% of 30 million eligible patients currently receiving biologics
- Topline data won't be available until Q2 2025
- Treatment requires ongoing maintenance therapy
Insights
The completion of target enrollment in REZOLVE-AD Phase 2b trial represents a significant milestone for Nektar's rezpegaldesleukin program. The 396-patient study achieved enrollment in just 14 months, indicating strong interest from both physicians and patients. The trial's design is particularly robust with its multi-regional approach spanning Europe (67%), US (17%), Canada (11%) and Australia (5%).
The study's focus on treatment-naïve patients (no prior biologics/JAK inhibitors) is strategically important, as it targets the 90% of eligible patients not currently receiving biological treatments. The trial's comprehensive endpoint structure, including EASI score improvement, vIGA-AD, EASI-75 and Itch NRS, will provide valuable efficacy data across multiple clinically relevant measures.
Key differentiators include the novel IL-2R agonist mechanism and the potential for durable response up to 36 weeks post-treatment cessation, which could represent a significant advantage over existing therapies. The maintenance phase design, comparing monthly versus quarterly dosing, could establish optimal treatment protocols for long-term management.
From a market perspective, this development is particularly compelling given the substantial untapped market in atopic dermatitis treatment. With only 10% of 30 million eligible patients currently receiving biologics in the US and Europe, there's significant room for market penetration. The rapid enrollment pace suggests strong market demand and physician buy-in for novel treatment mechanisms.
The trial's strategic patient selection criteria and global site distribution enhance the commercial viability of the results. The focus on moderate-to-severe cases, coupled with the exclusion of biologic-experienced patients, positions rezpegaldesleukin to potentially capture a significant portion of the first-line biologic treatment market.
The Q2 2025 timeline for topline data readout could position Nektar well in the competitive landscape, especially if the durability advantage is confirmed. For a company with a market cap of
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
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:
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," "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
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- 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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