ASITI-201 (proinsulin peptide / calcitriol liposomes)
UniQuest / University of Queensland (Liperate Therapeutics)
An antigen-specific liposome that packages a proinsulin peptide with calcitriol (active vitamin D), being tested in a Queensland Phase 1 trial in adults with stage 3 T1D. The registry says Part A is complete and Part B is recruiting. No efficacy results are posted.
The scorecard
The registered trial is a safety study. Mixed-meal C-peptide is a Part B secondary measure at three months, not a posted result. Mouse control of disease is not human preservation.[1]
Follow-up in the protocol is measured in weeks to three months. There is no evidence that any immune effect lasts after the injections stop.[1]
Primary endpoint is short-term safety of single and multiple subcutaneous doses. Part A (single-dose escalation) is complete and the safety committee allowed Part B (three weekly doses). That is protocol progress, not a published safety table.[1]
Adults 18–55 with stage 3 T1D diagnosed within five years, residual C-peptide at least 0.2 nmol/L (about 0.6 ng/mL), at least one islet autoantibody, and HLA-DQ8 or HLA-DQ2 (DQB1-03:02 or DQB1-02:01). Not children, not stage 1–2, not HLA-unselected.[1]
Human Phase 1, placebo-controlled, recruiting in Queensland. Target n=36; accrual 27 as of the 2 July 2026 registry update. No results posted, no Phase 2, no approval path.[1]
The full picture
ASITI-201 is a second-generation antigen-specific immunotherapy: a tiny fat particle that carries a piece of proinsulin together with calcitriol, injected under the skin. The idea is to re-teach immune cells to tolerate beta-cell protein rather than attack it. That is a real scientific hypothesis. It is not a treatment you can get, and it has not been shown to preserve insulin production in people.
The only registered human study is a Queensland Phase 1 (ACTRN12624001043527) in adults with stage 3 T1D, residual C-peptide, and selected HLA-DQ types. Part A (single-dose escalation) is complete; Part B (three weekly doses) is recruiting. Safety is the primary question. A three-month mixed-meal C-peptide test in Part B is secondary. Until those numbers are posted, this record stays an early safety programme — scored like other first-in-human antigen vaccines, not like teplizumab.
Coming soon
ETA · Phase 1 recruiting in Queensland; no efficacy timeline
Sources
- [1]ASITI-201-T1D: safety, tolerability and immune modulation of proinsulin peptide/calcitriol liposomes in stage 3 T1D · registry · 2026-07-02 — ACTRN12624001043527. Recruiting. Last updated 2 July 2026. Target n=36; accrual to date 27. Part A complete; Part B recruiting. First participant 13 November 2024. Anticipated last enrolment 31 October 2026.
- [2]World-first immunotherapy trial to treat Type 1 diabetes · news · 2025-04-11 — University of Queensland announcement that dosing had begun. A press count of early participants is not a result and is older than the registry's 27-person accrual.