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First Human Trial of Type 1 Diabetes Immunotherapy Underway in Australia

ASITI-201 aims to retrain the immune system to protect insulin-producing cells, with five participants already dosed in a groundbreaking safety study.

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Overview

  • The University of Queensland has initiated a world-first clinical trial of ASITI-201, an immunotherapy targeting the autoimmune cause of type 1 diabetes.
  • Five adult participants have received the drug at Brisbane’s Princess Alexandra Hospital, with plans to enroll 36 in a blinded, multi-dose safety study including placebo controls.
  • ASITI-201 combines pancreatic protein fragments and vitamin D to calm the immune system and protect insulin-producing beta cells from destruction.
  • Preclinical studies demonstrated the drug’s efficacy in controlling type 1 diabetes in mice, paving the way for human trials.
  • If successful, this therapy could reduce or eliminate the need for lifelong insulin injections and potentially prevent disease progression.