Nektar Announces Trial for Rezpegaldesleukin in Type 1 Diabetes

Nektar Therapeutics and TrialNet, an international clinical trial network at the forefront of diabetes research, announced a new collaboration agreement to evaluate Nektar's rezpegaldesleukin in patients with new onset stage 3 type 1 diabetes mellitus (T1D).

Rezpegaldesleukin is a novel agonistic T regulatory (Treg) cell biologic that is designed to both dampen the inflammatory response and simultaneously restore immune balance by directly expanding functional Treg cells and engaging multiple immunoregulatory pathways. Tregs are known to play a key role in the pathogenesis of 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 programme under the collaboration.

""We are looking forward to collaborating with the exceptional team at TrialNet to advance rezpegaldesleukin in an important clinical study to evaluate its potential in patients with newly-diagnosed type 1 diabetes,"" said Jonathan Zalevsky, PhD, senior vice president and chief research & development officer of Nektar. ""Our goal is to initiate this study in 2025. We are proud to support TrialNet's mission of advancing innovative mechanisms aimed at slowing or stopping the progression of type 1 diabetes.""

The new study will use a mixed meal tolerance test (MMTT) to measure the efficacy of rezpegaldesleukin or placebo for preserving C-peptide area under the curve over a 12-month duration comprised of a 6-month treatment period and a 6-month follow-up. Secondary objectives include pharmacokinetics, pharmacodynamics, and additional disease assessments including HbA1c levels and patient insulin requirements.

""We are excited to explore the potential of the Treg stimulator rezpegaldesleukin as a novel investigational candidate in people with type 1 diabetes,"" said Kevan C. Herold, MD, TrialNet Chair and C.N.H. Long Professor of Immunobiology and Medicine at Yale University. ""Rezpegaldesleukin provides an important opportunity to evaluate the therapeutic potential of using Tregs to directly target T-cell and cytokine-mediated destruction of beta-cells in the pancreas.""

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 wholly-owned by Nektar Therapeutics. It is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. It is currently being evaluated in the REZOLVE-AD study, a randomized, double blind, placebo-controlled phase 2b clinical trial for treatment of patients with moderate-to-severe atopic dermatitis (NCT06136741). 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).

The US Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of adult and paediatric 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.

T1D is an immune-mediated disease in which insulin-producing beta cells are completely, or almost completely, destroyed, resulting in life-long dependence on exogenous insulin. It is a chronic and potentially disabling disease that represents a major public health and clinical concern. Most individuals with newly diagnosed T1D have 10%–20% of beta-cell function remaining at the time of diagnosis.3 Preservation of residual beta-cell function at diagnosis may improve glycaemic control and reduce longer-term complications.

TrialNet is sponsored and funded by the National Institutes of Health (NIH), primarily through the Special Statutory Funding Programme for Type 1 Diabetes through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). TrialNet is the largest clinical trial network ever assembled to change the course of type 1 diabetes, and its mission is to prevent T1D and stop disease progression by preserving insulin production before and after diagnosis.

Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases.

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