Nektar and TrialNet Partner to Test Novel T-Cell Therapy Rezpegaldesleukin in Early-Stage Type 1 Diabetes
Key Insights
Nektar Therapeutics and TrialNet (search) have announced a collaboration to evaluate rezpegaldesleukin, a first-in-class T regulatory cell stimulator, in patients with new-onset type 1 diabetes (search).
The Phase 2 randomized trial will enroll approximately 70 adults and children, measuring C-peptide preservation over 12 months to assess the drug's potential to slow disease progression.
Rezpegaldesleukin works by expanding regulatory T cells to restore immune balance, targeting the underlying autoimmune mechanism of type 1 diabetes (search).
Nektar Therapeutics and TrialNet (search) have joined forces to investigate a potential breakthrough therapy for newly diagnosed type 1 diabetes (search) patients. The collaboration will evaluate rezpegaldesleukin, a novel T regulatory (Treg) cell stimulator, in a Phase 2 clinical trial targeting the disease's autoimmune mechanism.
Trial Design and Objectives
The randomized, double-blind, placebo-controlled study will involve approximately 70 participants with new onset stage 3 type 1 diabetes (search) mellitus (T1D). The trial's primary endpoint will measure C-peptide preservation using a mixed meal tolerance test over a 12-month period, comprising six months of treatment followed by six months of follow-up.
Secondary objectives include analyzing pharmacokinetics, pharmacodynamics, and key disease markers such as HbA1c levels and insulin requirements. The study is scheduled to begin in 2025, with Nektar providing the investigational drug and analytical support while retaining all program rights.
Innovative Mechanism of Action
Rezpegaldesleukin represents a novel approach to treating T1D by targeting the interleukin-2 receptor (search) complex. The drug is designed to stimulate the proliferation of regulatory T cells, which play a crucial role in maintaining immune system balance and are known to be significant in T1D pathogenesis.
"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," explained Dr. Kevan C. Herold, TrialNet (search) Chair and Professor at Yale University.
Clinical Significance and Market Position
The timing of this trial is particularly significant, as most individuals with newly diagnosed T1D retain only 10-20% of their beta-cell function at diagnosis. Preserving this residual function could improve glycemic control and reduce long-term complications.
"We are looking forward to collaborating with the exceptional team at TrialNet (search) to advance rezpegaldesleukin in an important clinical study," said Jonathan Zalevsky, PhD, Senior Vice President and Chief Research & Development Officer of Nektar. "Our goal is to support TrialNet's mission of advancing innovative mechanisms aimed at slowing or stopping the progression of type 1 diabetes (search)."
Broader Development Program
Rezpegaldesleukin is currently being evaluated in multiple clinical trials, including the REZOLVE-AD study for moderate-to-severe atopic dermatitis (search) and the REZOLVE-AA study for severe-to-very-severe alopecia areata (search). The FDA has granted Fast Track designation for its development in atopic dermatitis, highlighting the drug's potential significance in treating autoimmune conditions.