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Ashvattha Therapeutics Enrolls First Patient in Extended Phase 1/2 Trial of Imaging Agent 18F-OP-801 for Additional Neurological Conditions

Friday, February 23, 2024

Ashvattha Therapeutics has initiated enrollment of the first patient in its expanded Phase 1/2 trial of 18F-OP-801, a hydroxyl dendrimer (HD) imaging agent. This trial aims to evaluate the safety, pharmacokinetics, and biodistribution of intravenously administered 18F-OP-801 in patients diagnosed with amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD), multiple sclerosis (MS), and Parkinson's disease (PD).

Ashvattha Therapeutics, underscored the significance of this study, which builds upon preclinical evidence indicating 18F-OP-801's ability to penetrate the blood-brain barrier and target activated microglia in regions of neuroinflammation across various disease models. Cleland highlighted that preliminary findings from the initial phase of the trial confirmed negligible uptake in the brains of healthy volunteers, as anticipated. The focus now shifts to enrolling patients with neurodegenerative disorders to investigate 18F-OP-801 uptake in neuroinflammation regions, potentially serving as a companion biomarker for Ashvattha's HD therapeutics.

The Phase 1/2 study aims to enroll up to 20 subjects with ALS, AD, MS, and PD, focusing on evaluating 18F-OP-801's safety, distribution, clearance, and ability to detect neuroinflammation via PET imaging compared to healthy counterparts. Additionally, the study aims to correlate PET imaging signals with disease biomarkers and clinical assessments, while also assessing test-retest repeatability of 18F-OP-801 uptake in a subset of subjects.

18F-OP-801, a HD imaging agent, demonstrates promising features in crossing the blood-brain barrier and targeting activated microglia and macrophages in neuroinflammation regions in animal models. This potential allows for precise visualization and monitoring of neuroinflammation progression in human neurodegenerative diseases through serial imaging with 18F-OP-801. Furthermore, its distribution in the body enables estimating the amount of HD therapeutic reaching brain cells, offering potential applications as a companion biomarker for treating ALS, AD, MS, and PD.



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