First Patient Enrolled in Phase 1/2 Neurological Study of 18F-OP-801 Imaging Agent

Ashvattha Therapeutics, a company focused on developing nanomedicines that can penetrate tissue barriers to target activated cells in inflammatory areas, has initiated an expanded Phase 1/2 clinical trial for 18F-OP-801. This imaging agent is designed to cross the blood-brain barrier and is being tested for its safety and ability to target neuroinflammation in patients with ALS, Alzheimer's, MS, and Parkinson's diseases.

The first patient has been enrolled in the study, which will assess the pharmacokinetics and biodistribution of 18F-OP-801 after intravenous administration. The agent has previously shown promise in preclinical studies, where it was able to cross the blood-brain barrier and be taken up by activated microglia in areas of neuroinflammation across various disease models. The first part of the clinical trial indicated no significant uptake in the brains of healthy individuals, aligning with expectations.

Jeffrey Cleland, Ashvattha's Chairman, President, and CEO, highlighted the significance of the study, stating that it will focus on subjects with neurodegenerative conditions to determine the uptake of 18F-OP-801 in neuroinflammation areas. This will support the agent's use as a companion biomarker for one of Ashvattha's hydroxyl dendrimer therapeutics.

The Phase 1/2 study plans to enroll up to 20 subjects and will measure the biodistribution, clearance, and PET imaging capabilities of 18F-OP-801 to detect neuroinflammation. It will also explore the correlation between imaging signals, biomarkers of disease activity, and clinical assessments, as well as the repeatability of 18F-OP-801 uptake.

18F-OP-801 is a hydroxyl dendrimer imaging agent that has demonstrated its ability to target activated microglia and macrophages in neuroinflammation regions across animal models. The studies suggest that it can visualize the extent and progression of neuroinflammation with high specificity and sensitivity in human neurodegenerative diseases. The amount of 18F-OP-801 in the brain can estimate the amount of HD therapeutic reaching the same cells, enabling an image-treat-reimage approach using 18F-OP-801 as a companion biomarker for treating ALS, Alzheimer's, MS, and Parkinson's diseases.

Ashvattha Therapeutics is pioneering a new class of nanomedicine therapeutics that selectively target activated cells in inflammatory regions, aiming to set a new standard in precision medicine across various fields such as ophthalmology, neurology, and inflammation.