The Generative Brain
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NIH NeuroNEXT (NINDS)

NIH NINDS NeuroNEXT clinical trial network that funds and hosts the PRiSM project (NN112), including its five clinical sites and observational arm.

Key facts

  • The NN112 PRiSM page states the team developed a divalent siRNA drug candidate, completed manufacturing and filed an IND with the FDA.
  • Primary objective is safety and tolerability; secondary objectives are CSF PrP lowering and drug concentration in CSF and blood; exploratory objectives are biomarker and clinical endpoints.
  • An observational arm of newly diagnosed untreated patients gives a longitudinal biomarker comparator for this and future trials.
  • Protocol principal investigator is Eric Minikel; clinical sites listed are University Hospitals/Case Western, Columbia, MGH, Mayo Rochester and Vanderbilt.
  • The Prion Alliance states the Broad is the official sponsor and NIH NeuroNEXT pays for the trial.

Timeline

  1. 2026Trial launch announced.
  2. 2026PRiSM registry start date.
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