#United States #San Francisco #Type 1 Diabetes #Nektar Therapeutics #Rezpegaldesleukin

Nektar and TrialNet Announce New Agreement for Clinical Trial

In a significant development in diabetes research, Nektar Therapeutics has announced a collaboration with TrialNet, a renowned global clinical trial network, to evaluate the efficacy of their investigational drug, rezpegaldesleukin, in patients diagnosed with new onset stage 3 Type 1 Diabetes Mellitus (T1D). This collaboration was revealed on February 24, 2025, and is set to advance our understanding of treating this autoimmune disease.

Rezpegaldesleukin is a pioneering drug designed to modulate T regulatory (Treg) cells, which are crucial in managing immune responses. Tregs help maintain immune balance and prevent excessive inflammatory responses, an essential component in the context of T1D, where the immune system attacks insulin-producing beta cells in the pancreas. This innovative approach aims to restore some immune function, offering new hope for patients recently diagnosed with T1D.

The Clinical Trial Framework

Under the terms of their agreement, TrialNet will lead a Phase 2 randomized, double-blind, placebo-controlled clinical trial. Approximately 70 adults and children with new onset stage 3 T1D will participate in this study to assess both the safety and potential effectiveness of rezpegaldesleukin. Nektar will provide the necessary drug supplies and support for pharmacokinetic analyses and other study requirements. Notably, Nektar retains the rights to all developments relating to the rezpegaldesleukin program.

Jonathan Zalevsky, PhD, Senior Vice President and Chief Research Development Officer at Nektar, has expressed excitement about the collaboration, emphasizing the importance of rezpegaldesleukin in potentially changing treatment paradigms for T1D patients. The study is expected to initiate in 2025, reinforcing Nektar's commitment to improving lives through innovative medical solutions.

Innovation Through Research

The clinical study will utilize a mixed meal tolerance test (MMTT) over 12 months to evaluate the drug's efficacy in preserving C-peptide levels, a crucial marker of beta-cell function. Alongside primary efficacy measures, the trial will also focus on pharmacokinetics and pharmacodynamics, alongside other important assessments such as HbA1c levels and patient insulin requirements.

TrialNet officials are equally optimistic about this research opportunity. Dr. Kevan C. Herold, TrialNet Chair and Yale University immunobiology specialist, stated the initiative’s potential to explore Treg stimulator rezpegaldesleukin as a novel investigational candidate for T1D treatment. By directly targeting T-cell and cytokine-mediated destruction of pancreatic beta cells, rezpegaldesleukin may offer a new therapeutic approach in this challenging disease area.

The Significance of Rezpegaldesleukin

Rezpegaldesleukin stands out as a first-in-class resolution therapy that directly addresses immune imbalances associated with autoimmune and inflammatory diseases. It targets the interleukin-2 receptor complex, massively stimulating Treg proliferation. This action could fundamentally alter the immune response and ideally help in managing conditions associated with immune dysfunction, including T1D. Nektar has a robust pipeline, with rezpegaldesleukin also under investigation for treating moderate-to-severe atopic dermatitis and alopecia areata in concurrent clinical trials.

The Bigger Picture: Type 1 Diabetes

Type 1 diabetes is a chronic condition resulting from the destruction of insulin-producing beta cells, leaving patients reliant on external insulin. Newly diagnosed individuals typically retain only 10-20% of their beta-cell function, highlighting the critical need for innovative strategies to preserve this function to enhance long-term management outcomes.

Nektar Therapeutics, headquartered in San Francisco, remains committed to advancing healthcare through cutting-edge biotechnology focused on immunological dysfunction. The partnership with TrialNet exemplifies a strategic move aimed at paving the way for new advancements in T1D treatment and beyond.

With the combined efforts of Nektar Therapeutics and TrialNet, the hope is to not only develop a clinically effective therapy but also to provide much-needed alternatives for those battling Type 1 Diabetes. As the trial progresses, the diabetes community and the medical field will be closely watching the outcomes for potential breakthroughs in this serious condition.