Nektar Therapeutics Advances Diabetes Research with New Clinical Trial Agreement for Rezpegaldesleukin

San Francisco, CA – Nektar Therapeutics (Nasdaq: NKTR) announced on February 24, 2025, that it has entered into a clinical trial agreement with TrialNet, an international clinical trial network known for its leadership in diabetes research. The new collaboration will evaluate Nektar’s investigational agent, rezpegaldesleukin, in patients newly diagnosed with stage 3 type 1 diabetes mellitus (T1D).

Under the agreement, TrialNet will design, conduct, and fund a Phase 2 randomized, double-blind, placebo-controlled clinical trial to assess the safety and potential efficacy of rezpegaldesleukin. The study is planned to enroll approximately 70 adult and pediatric patients with newly diagnosed T1D, with the trial expected to launch later in 2025. Participants will undergo a mixed meal tolerance test (MMTT) to evaluate the preservation of beta-cell function via measurement of C-peptide area under the curve over a 12-month period, which includes a 6-month treatment phase followed by a 6-month follow-up. Secondary endpoints will include pharmacokinetics, pharmacodynamics, HbA1c levels, and assessments of insulin requirements.

Nektar will supply rezpegaldesleukin for the trial and support the study with pharmacokinetic and related analyses, while retaining all rights to its rezpegaldesleukin program. The investigational agent is designed to enhance the number and function of regulatory T cells, potentially restoring immune balance by dampening inflammatory responses—a mechanism that may counteract the autoimmune destruction of beta cells commonly seen in T1D.

Commenting on the collaboration, Jonathan Zalevsky, PhD, Senior Vice President and Chief Research & Development Officer at Nektar, stated, “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. Our goal is to initiate this study in 2025.”

TrialNet, sponsored and funded by the National Institutes of Health primarily through the Special Statutory Funding Program for Type 1 Diabetes (administered by the National Institute of Diabetes and Digestive and Kidney Diseases), will leverage its extensive experience in T1D research to support this important study. Dr. Kevan C. Herold, Chair of TrialNet, also highlighted the potential of the study, noting that rezpegaldesleukin may offer a novel therapeutic approach to targeting the immune mechanisms underlying T1D.

This clinical trial represents a significant step in Nektar’s efforts to develop innovative treatments that address the underlying immunological dysfunction in autoimmune and inflammatory diseases. The collaboration underscores the company’s commitment to advancing research that could ultimately slow or halt the progression of type 1 diabetes.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Nektar Therapeutics’s 8K filing here.

About Nektar Therapeutics

Nektar Therapeutics, a biopharmaceutical company, focuses on discovering and developing medicines in the field of immunotherapy in the United States and internationally. The company is developing rezpegaldesleukin, a cytokine Treg stimulant that is in phase 2 clinical trial for the treatment of systemic lupus erythematosus and ulcerative colitis, as well as phase 2b clinical trial to treat atopic dermatitis and psoriasis; and NKTR-255, an IL-15 receptor agonist, which is in phase 1 clinical trial to boost the immune system's natural ability to fight cancer.