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

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

Nektar Therapeutics Announces Two Abstracts Accepted at EADV Congress 2023 for Rezpegaldesleukin, a First-in-Class Selective Regulatory T-cell Therapy (PRNewswire) - "Nektar Therapeutics...announced today that it will have two presentations for rezpegaldesleukin (REZPEG), a first-in-class selective regulatory T-cell (Treg) therapy, at the 2023 European Academy of Dermatology and Venereology (EADV) Congress to be held October 11-14 in Berlin."

Late-breaking abstract • P1 data • P2b data • Atopic Dermatitis • Immunology

Nektar Therapeutics Announces Two Abstracts Accepted at EADV Congress 2023 for Rezpegaldesleukin, a First-in-Class Selective Regulatory T-cell Therapy (PRNewswire) - "Nektar Therapeutics...announced today that it will have two presentations for rezpegaldesleukin (REZPEG), a first-in-class selective regulatory T-cell (Treg) therapy, at the 2023 European Academy of Dermatology and Venereology (EADV) Congress to be held October 11-14 in Berlin....Details of the presentations at EADV are as follows: 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...Authors: Leon Kircik...A Phase 2b, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in Adults with Moderate-to-Severe Atopic Dermatitis (Abstract #6218/ePoster #P0559...Authors: Andrew Blauvelt..."

A Phase 2b, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in Adults with Moderate-to-Severe Atopic Dermatitis (EADV 2023) - "REZPEG is a novel regulatory T cell stimulating therapy that may confer prolonged therapeutic benefit for patients with moderate-to-severe AD. This phase 2b trial is evaluating the efficacy and safety of multiple induction and maintenance dosing regimens of REZPEG in biologic naïve patients with moderate-to-severe atopic dermatitis."

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL2

Nektar Therapeutics Announces Promising New Data from Phase 1b Study of Rezpegaldesleukin in Moderate-to-Severe Atopic Dermatitis (PRNewswire) - P1b | N=40 | NCT04081350 | Sponsor: Eli Lilly and Company | "Nektar Therapeutics...announced new data for rezpegaldesleukin in patients with atopic dermatitis, including new clinical efficacy endpoints from the Phase 1b study....'These new data announced today for rezpegaldesleukin in atopic dermatitis demonstrate that, in addition to the strong previously reported efficacy for EASI-related endpoints, rezpegaldesleukin has the potential to be a differentiated therapeutic that could greatly improve quality-of-life for patients...'"

P1 data • Atopic Dermatitis • Immunology

Nektar Therapeutics Reports Second Quarter 2023 Financial Results (PRNewswire) - "...'We look forward to initiating a Phase 2b study of rezpegaldesleukin in patients with atopic dermatitis and achieving our objective to have initial data from this study in the first half of 2025'."

New P2b trial • P2b data • Atopic Dermatitis • Dermatitis • Immunology • Inflammation

Nektar Announces Promising New and Corrected Rezpegaldesleukin Efficacy Data Which Were Previously Reported in 2022 and Incorrectly Calculated by Former Collaborator Eli Lilly & Company (PRNewswire) - P1b | N=30 | NCT04119557 | P1b | N=40 | NCT04081350 | Sponsor: Eli Lilly and Company | "Nektar Therapeutics...today announced that efficacy data previously generated by Eli Lilly & Company for rezpegaldesleukin (REZPEG) that were presented at the September 2022 EADV Congress were incorrectly calculated by Lilly....Specifically, the new and corrected data from the atopic dermatitis study demonstrate that 12 weeks of REZPEG therapy at the highest dose resulted in a mean Eczema Area and Severity Index (EASI) score improvement of 83% with a p-value of 0.002 as compared to placebo and an EASI-75 response rate of 41%....REZPEG also provided a more rapid and steep drop in EASI scores immediately after therapy initiation than the previously reported erroneous data indicated. This efficacy benefit was also maintained for 36 weeks without additional treatment after the 12-week induction period."

P1 data • Atopic Dermatitis • Immunology • Psoriasis

ISLAND-SLE: A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2 | N=291 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Phase I Study of LY3471851 in Healthy Participants (clinicaltrials.gov) - P1 | N=41 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion

Nektar Therapeutics Announces Phase 2 Topline Data for Rezpegaldesleukin in Patients with Systemic Lupus Erythematosus (PRNewswire) - P2 | N=280 | ISLAND (NCT04433585) | Sponsor: Eli Lilly | "Nektar Therapeutics...announced topline data from a Phase 2 randomized, double-blind, placebo-controlled study of rezpegaldesleukin (also known as LY3471851 or REZPEG) in adults with moderately-to-severely active systemic lupus erythematosus (SLE) despite receiving standard-of-care treatment such as corticosteroids, anti-malarials, and non-biological immunosuppressants....Although the mid-dose level demonstrated a numeric improvement in SLEDAI-2K score as compared to placebo (with a placebo-adjusted response of 8.8% for the modified intent-to-treat (mITT) population [p=0.309] and 13.9% for the per protocol population [p=0.06]), the primary endpoint was not met."

P2 data • Inflammation • Lupus • Systemic Lupus Erythematosus