Dalazatide (formerly ShK-186) is a first-in-class drug designed to selectively target cells that cause autoimmune diseases while the patient’s protective immune response is left unaffected. Such autoimmune diseases include lupus, psoriasis, rheumatoid arthritis, inflammatory bowel diseases, Type 1 diabetes mellitus, and multiple sclerosis (MS).
The therapy is a synthetic analog of a peptide extracted from a Caribbean Sea anemone. It inhibits the Kv1.3 potassium channel and is an important new pharmaceutical target because of its expression on effector memory T-cells (a subset of the T-cell family that leads to inflammation and tissue damage in autoimmune diseases).
Dalazatide blocks the activation of the effector memory T-cells but doesn’t suppress other T-cells subtype, which leaves the immune response intact. As a result, dalazatide may not cause broad immune suppression.
It is administered by injection into the skin twice a week. A sustained release formulation is being developed for use every three months.
Two completed safety and tolerability studies of dalazatide in healthy volunteers (NCT02446340) show good tolerability, no significant findings in medical and physical exams, and mild adverse events. Additionally, dalazatide demonstrated clinical proof-of-concept in a Phase 1b psoriasis trial that showed good tolerability, full completion for all participants, and mild adverse events. Phase 2 trials are under development.
Dalazatide is jointly developed by Kineta and KPI Therapeutics Inc.
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