Nektar Therapeutics (NKTR) and TrialNet said Monday that they agreed to collaborate to evaluate Nektar's drug, rezpegaldesleukin, in patients with new onset stage 3 type 1 diabetes mellitus.
Under the agreement, the companies said TrialNet will conduct a phase 2 trial involving about 70 adults and children to assess the safety and potential efficacy of the treatment, while Nektar will provide rezpegaldesleukin and support the study with pharmacokinetic analyses and other evaluations.
The companies said Nektar will retain all rights to the drug under the agreement.
The study will measure the drug's efficacy using a mixed meal tolerance test to assess C-peptide levels over a 12-month period, which includes a 6-month treatment phase and a 6-month follow-up, the companies said, adding secondary objectives include evaluating pharmacokinetics, pharmacodynamics, HbA1c levels, and insulin requirements.
Financial details of the partnership were not disclosed.
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