First Patient Enrolls in 18F-OP-801 Phase 1/2 Neurological Imaging Trial

Ashvattha Therapeutics has enrolled its first patient in an expanded Phase 1/2 trial of 18F-OP-801, an imaging agent designed to cross the blood-brain barrier and target neuroinflammation. This study will assess the safety, distribution, and pharmacokinetics of 18F-OP-801 in patients with amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), multiple sclerosis (MS), and Parkinson’s disease (PD).

The trial aims to evaluate the ability of 18F-OP-801 to localize regions of neuroinflammation using PET imaging, with preliminary results anticipated in the first half of 2024. Up to 20 participants with neurodegenerative conditions as well as age-matched healthy controls will be part of the study. Additional aims include validating the imaging signals against disease biomarkers and clinical evaluations, along with test/retest consistency in certain subjects.

18F-OP-801 is noted for its capacity to cross the blood-brain barrier and selectively bind to activated microglia and macrophages in neuroinflammatory areas, an ability demonstrated in multiple animal models. This technique could reveal detailed information about the extent and progression of neuroinflammation in human neurodegenerative diseases.

The study's findings will be significant in setting 18F-OP-801 as a biomarker companion for HD therapeutics, potentially providing a framework for treatment evaluation in diseases such as ALS, AD, MS, and PD.

Ashvattha Therapeutics focuses on developing nanomedicine therapeutics that penetrate tissue barriers and selectively target cells in inflamed regions. This novel approach aims to revolutionize precision medicine across various fields, particularly in ophthalmology, neurology, and inflammation.

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