OP-801

Neuroinflammation Pipeline Enables Patient Selection

THE NEED

  • Chronic neuroinflammation, inflammation in the brain or spinal cord, correlates with poor outcomes in a wide range of diseases (e.g. ALS, Alzheimer’s, Parkinson’s)

  • Neuroinflammation is difficult to diagnose, and current diagnostics lack sufficient selectivity

OUR SOLUTION

  • Developed a biomarker (18F-OP-801) that is selectively taken up by reaction microglia in regions of neuroinflammation in multiple animal models
  • Provides a method to measure HD uptake in the brain to select patients
  • Because all HDs distribute the same way in the body, the amount of 18F-OP-801 in the brain provides an estimate of the amount of HDT that will get to the same cells in the brain
  • HDs have been observed to cross BBB in 7 animal species only when neuroinflammation is present

Leveraging OP-801 to Achieve Human POC

OP-801 Phase 1 Neuroinflammation

Selective Targeting to Neuroinflammation in Alzheimer’s Disease Mice

Selective Targeting to Neuroinflammation in Alzheimer’s Disease Mice

OP-801: Phase 1/2 Proof of Targeting Neuroinflammation in ALS Patients

Phase 1/2 – Age Matched Healthy Volunteers and ALS Patients

  • Safety & Tolerability of 18F-OP-801
  • Pharmacokinetics & Dosimetry of 18F-OP-801
  • Optimize PET scan for future studies – Optimal Dose & Scan Time
  • ALS vs Normal Healthy Adults PET images – Demonstration of Selectivity (analogous to 5xFAD mouse data)

TIMELINES

  • FPI in Q3 2022
  • LPI in Q1 2023

Expand to Image-Treat-ReImage Study in 1H 2023