Nektar Announces Clinical Trial Agreement to Evaluate Rezpegaldesleukin in Patients with New Onset Type 1 Diabetes Mellitus

Core Viewpoint - Nektar Therapeutics and TrialNet have announced a collaboration to conduct a Phase 2 clinical trial evaluating the safety and efficacy of rezpegaldesleukin in patients with new onset stage 3 type 1 diabetes mellitus (T1D) [1][2][3] Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases, with rezpegaldesleukin as its lead product candidate [10] - Rezpegaldesleukin is a novel agonistic T regulatory (Treg) cell biologic designed to restore immune balance and dampen inflammatory responses [2][5] - The drug is wholly owned by Nektar and is also being evaluated in clinical trials for atopic dermatitis and alopecia areata [6][10] Clinical Trial Details - The Phase 2 trial will be randomized, double-blind, and placebo-controlled, involving approximately 70 adults and children with new onset stage 3 T1D [2][3] - The study aims to measure the efficacy of rezpegaldesleukin using a mixed meal tolerance test (MMTT) over a 12-month period, including a 6-month treatment phase and a 6-month follow-up [3] - Secondary objectives will include pharmacokinetics, pharmacodynamics, and assessments of HbA1c levels and patient insulin requirements [3] Industry Context - Type 1 diabetes (T1D) is an immune-mediated disease characterized by the destruction of insulin-producing beta cells, leading to lifelong dependence on insulin [9] - Preservation of residual beta-cell function at diagnosis can improve glycemic control and reduce long-term complications [9] - TrialNet is the largest clinical trial network focused on changing the course of T1D, aiming to prevent the disease and preserve insulin production [11]