rezpegaldesleukin (NKTR-358) / Nektar Therap - LARVOL DELTA

Nektar Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results (PRNewswire) - "...'With enrollment now complete for the atopic dermatitis...Phase 2b trial, we are on track to report topline data for rezpegaldesleukin in the second quarter...of this year'....'We plan to submit the IND for NKTR-0165 in the second half of this year'."

IND • P2b data • Atopic Dermatitis • Immunology • Inflammation

Safety profile of Rezpegaldesleukin, A Selective Regulatory T-Cell-Inducing Interleukin-2 Conjugate, versus Placebo Based on Aggregate Safety Evaluation of 746 Subjects Enrolled Across 9 Studies (AAD 2025) - P1, P2 | "REZPEG is a novel regulatory T cell stimulating therapy and pooled safety analysis demonstrates a consistent and potentially favorable safety profile. Two Phase 2b, double-blind studies are currently ongoing, evaluating REZPEG in subjects with moderate-to-severe AD (NCT06136741) and severe alopecia areata (NCT06340360)."

Clinical • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lupus • Psoriasis • Ulcerative Colitis • IL2

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) (clinicaltrials.gov) - P2 | N=86 | Active, not recruiting | Sponsor: Nektar Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Alopecia • Dermatology • Immunology

Nektar Therapeutics Announces Completion of Target Enrollment in REZOLVE-AA Phase 2b Clinical Trial of Rezpegaldesleukin in Patients with Severe-to-Very Severe Alopecia Areata (PRNewswire) - "Nektar Therapeutics...announced the company has completed target enrollment in its REZOLVE-AA Phase 2b study of rezpegaldesleukin in patients with severe-to-very-severe alopecia areata....The REZOLVE-AA (NCT06340360) study enrolled patients with severe-to-very-severe alopecia areata who have not received a JAK inhibitor or other biologic. Patients were randomized across two different dose regimens of rezpegaldesleukin or placebo....Patients were enrolled across approximately 30 sites globally with: 62% enrolled in Poland; 24% enrolled in Canada; and 14% enrolled in the United States....'We look forward to reporting our topline data from this study in the fourth quarter of this year'."

Enrollment closed • P2b data • Alopecia

Nektar Announces Clinical Trial Agreement to Evaluate Rezpegaldesleukin in Patients with New Onset Type 1 Diabetes Mellitus (PRNewswire) - "Nektar Therapeutics...today announced a new collaboration agreement to evaluate Nektar's rezpegaldesleukin in patients with new onset stage 3 type 1 diabetes mellitus (T1D)...Under the agreement, TrialNet will conduct the Phase 2 randomized, double-blind, placebo-controlled, clinical trial to investigate the safety and potential efficacy of rezpegaldesleukin in approximately 70 adults and children with new onset stage 3 T1D. Nektar will supply rezpegaldesleukin for the trial and will provide support for the study, including pharmacokinetic and other analyses. Nektar will retain all rights to the rezpegaldesleukin program under the collaboration...'Our goal is to initiate this study in 2025.'"

Commercial • New P2 trial • Type 1 Diabetes Mellitus

Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis (PRNewswire) - "Nektar Therapeutics...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells (Tregs)...'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.'"

Fast track • P2b data • Atopic Dermatitis

REZOLVE-AD: A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=396 | Active, not recruiting | Sponsor: Nektar Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Nektar Therapeutics Announces Completion of Target Enrollment in REZOLVE-AD Phase 2b Clinical Trial of Rezpegaldesleukin in Patients with Moderate-to-Severe Atopic Dermatitis (PRNewswire) - "Nektar Therapeutics...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."

Enrollment closed • Atopic Dermatitis

REZOLVE-AD: A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=396 | Recruiting | Sponsor: Nektar Therapeutics | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Nektar Announces Publication in Nature Communications of Results from Phase 1b Studies of Rezpegaldesleukin in Two Inflammatory Skin Diseases (PRNewswire) - P1 | N=48 | NCT04081350 | P1 | N=30 | NCT04119557 | Sponsor: Nektar Therapeutics | "Nektar Therapeutics...today announced the publication of peer-reviewed data from two Phase 1b studies in Nature Communications highlighting the efficacy, safety, and tolerability of rezpegaldesleukin in patients with atopic dermatitis (AD) and psoriasis (PsO)....Rezpegaldesleukin is safe and well-tolerated and demonstrates consistent pharmacokinetics in participants receiving subcutaneous doses of 10 to 12 μg/kg or 24 μg/kg once every 2 weeks for 12 weeks, meeting the primary and secondary objectives of each study; AD patients receiving high dose rezpegaldesleukin demonstrate an 83% improvement in EASI score after 12 weeks of treatment EASI improvement of ≥ 75% (EASI-75) and vIGA-AD responses are maintained for 36 weeks after treatment discontinuation in 71% and 80% of week 12 responders, respectively..."

P1 data • Atopic Dermatitis • Immunology • Psoriasis

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. (PubMed, Nat Commun) - P1 | "These exploratory clinical improvements are accompanied by sustained increases in CD25bright Tregs. REZPEG thus represents a homeostatic approach to cutaneous disease therapy and holds clinical potential in providing long-term, treatment-free disease control."

Clinical • Journal • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis

A Phase 2b Study Evaluating the Efficacy and Safety of Single Agent Rezpegaldesleukin, an Interleukin-2 Receptor (IL-2R) Pathway Agonist, in the Treatment of Severe to Very Severe Alopecia Areata (EADV 2024) - P2 | "REZPEG is a novel regulatory T cell stimulating therapy that may confer prolonged therapeutic benefit for patients with chronic inflammatory skin conditions, including AA and AD. This phase 2b trial is evaluating the efficacy and safety of multiple dosing regimens of REZPEG in JAK-inhibitor and biologic-therapy naïve patients with severe to very severe alopecia areata."

Clinical • P2b data • Alopecia • Atopic Dermatitis • Dermatitis • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Psoriasis • Systemic Lupus Erythematosus • IL2 • IL2RA

Serum proteomic biomarker analysis of the interleukin-2 receptor pathway agonist rezpegaldesleukin in patients with atopic dermatitis (EADV 2024) - "The serum proteomic biomarker analysis presented here provides a greater mechanistic understanding of the observed therapeutic effects of REZPEG in AD."

Biomarker • Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL2 • IL2RA

A Phase 2b, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled, International, Multicenter, Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in Adults with Moderate-to-Severe Atopic Dermatitis (EADV 2024) - "REZPEG represents an innovative approach to stimulate regulatory T cells, potentially offering lasting benefits for patients with moderate-to-severe AD. This Phase 2b trial seeks to define the optimal dosing schedule and further establish the efficacy and safety profile of REZPEG in a population new to biologic and JAK inhibitor therapies."

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL2RA

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Nektar Therapeutics | Trial completion date: Feb 2026 ➔ Aug 2026

Trial completion date • Alopecia • Dermatology • Immunology

Nektar Therapeutics Announces Multiple Presentations for Rezpegaldesleukin at EADV 2024 (PRNewswire) - "New proteomic analyses show that rezpegaldesleukin increases the protein levels of immune-regulating pathways while reducing specific serum proteins known to be elevated in patients with atopic dermatitis...In addition to two trial-in-progress posters, new proteomic analyses were presented that showcases a unique serum proteomic profile in patients with atopic dermatitis (AD)...The data show that REZPEG induces important immunoregulatory pathways, such as IL-10, a key anti-inflammatory cytokine. In addition, REZPEG reduced specific cytokines and chemokines which are known to be elevated in patients with atopic dermatitis and other atopy diseases, including IL-15, CCL22, CX3CL1, and IL-19...Nektar expects topline data from the AD study in the first half of 2025 and topline data from the AA study in the middle of 2025."

Clinical data • P1 data • P2b data • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Recent patents in allergy and immunology: The interleukin-2 receptor pathway agonist rezpegaldesleukin (REZPEG) for the rescue of regulatory T cells in chronic inflammatory and autoimmune diseases. (PubMed, Allergy) - No abstract available

Biomarker • Clinical • Journal • Review • Allergy • Immunology • IL2

Nektar Therapeutics Reports First Quarter 2024 Financial Results (Nektar Therapeutics Press Release) - "Enrollment is ongoing in the Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis. The Company expects topline data from the study in the first half of 2025."

Enrollment status • P2b data • Atopic Dermatitis • Immunology

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Nektar Therapeutics

New P2 trial • Alopecia • Dermatology • Immunology

Nektar Therapeutics Announces Initiation of Phase 2b Clinical Study Evaluating Rezpegaldesleukin in Patients with Severe to Very Severe Alopecia Areata (PRNewswire) - "Nektar Therapeutics...today announced the initiation of its Phase 2b clinical trial evaluating rezpegaldesleukin in patients with severe to very severe alopecia areata....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."

New trial • P2b data • Alopecia • Immunology

Rezpegaldesleukin: Top-line data from P2b REZOLVE-AD trial (NCT06136741) in adults with moderate-to-severe atopic dermatitis in H1 2025 (Nektar Therapeutics, 44th Annual Cowen Health Care Conference)

P2b data • Atopic Dermatitis

Rezpegaldesleukin: Top-line data from P2b REZOLVE-AD trial (NCT06136741) in adults with moderate-to-severe atopic dermatitis in H1 2025 (Nektar Therapeutics, 44th Annual Cowen Health Care Conference)

P2b data • Atopic Dermatitis

REZOLVE-AD: A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=396 | Recruiting | Sponsor: Nektar Therapeutics

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Nektar Presents New Responder Data for Rezpegaldesleukin, a First-in-Class Selective Regulatory T-cell Therapy, in Late-Breaking News Oral Presentation at 2023 EADV Congress (PRNewswire) - P1b | N=40 | NCT04081350 | Sponsor: Eli Lilly and Company | "Nektar Therapeutics...today announced new data for rezpegaldesleukin (REZPEG)...at the 2023 European Academy of Dermatology and Venereology (EADV) Congress....At the highest studied dose, the proportion of Daily Life Quality Index (DLQI) responders was 75% and the proportion of Patient Oriented Eczema Measure (POEM) responders was 65% at week 12. The proportion of responders were generally sustained after treatment ended through the 36-week follow-up. This durability highlights REZPEG's disease remittive potential....Based on these data, the company is initiating two Phase 2 studies in atopic dermatitis and in alopecia areata. These trials are expected to initiate in October of this year and in early 2024, respectively. The trial design for the study in patients with moderate-to-severe atopic dermatitis was presented in an ePoster at EADV earlier this week."

Clinical protocol • Late-breaking abstract • New P2 trial • P1 data • Alopecia • Atopic Dermatitis • Immunology

Efficacy and Safety of Single Agent Rezpegaldesleukin, a Selective Regulatory T-Cell-Inducing Interleukin-2 Conjugate, in the Treatment of Atopic Dermatitis: Final Results from a Randomized Phase 1b Study (EADV 2023) - P1 | "In pts with moderate-to-severe AD, treatment with rezpegaldesleukin showed dose-dependent improvements in physician-assessed disease activity and pt-reported outcomes over 12 weeks of treatment, with post-treatment sustained efficacy over an additional 36 weeks. This durability highlights rezpegaldesleukin’s disease remittive potential. Treg increases were in line with prior studies and confirm the desired drug action."

Clinical • Late-breaking abstract • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • FOXP3 • IL2 • IL2RA • ISG20