First patient enrolled in phase 1/2 study of hydroxyl dendrimer imaging agent

Ashvattha Therapeutics announced that the first patient has been enrolled in a phase 1/2 study to evaluate the ability of an imaging agent to cross the blood-brain barrier and target key markers of neuroinflammation.

According to a company release, [¹⁸F]OP-801 is a hydroxyl dendrimer imaging agent that selectively targets reactive macrophages and microglia and may aid visualization of neuroinflammatory progression in diseases like ALS, Alzheimer’s disease and Parkinson’s disease.

The nonrandomized, open-label clinical trial, which is expected to enroll up to 26 individuals, will assess the safety, pharmacokinetics and biodistribution of a single IV dose of [¹⁸F]OP-801 in healthy volunteers and patients with ALS.

“The initiation of the clinical trial evaluating [¹⁸F]OP-801 as an imaging agent is a significant step to unlocking the potential of our proprietary [hydroxyl dendrimer] technology for treatment of neurological diseases,” Jeffrey Cleland, PhD, chairman, CEO and president of Ashvattha Therapeutics, stated in the release. “This approach, if successful, will reduce clinical risk by ensuring the correct amount of drug reaches the target to treat the neurological disease.”

The study will also measure biodistribution and clearance of the imaging agent in both groups and evaluate the uptake of [¹⁸F]OP-801 in regions of neuroinflammation in patients with ALS using positron emission tomography and CT scans, per the release.

“An obstacle to the treatment of neurodegenerative diseases like ALS is ensuring that treatment reaches areas of disease in the brain,” Farshad Moaradi, MD, PhD, clinical associate professor of radiology at Stanford Medicine, said in the release. “This study will determine if visualizing [¹⁸F]OP-801 uptake can pinpoint regions of inflammation and disease with enough specificity to provide insights into future patient selection, potentially making precision medicine even more precise.”