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
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