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Ashvattha Therapeutics Announces First Patient Enrolled in a Phase 1 Study of [18F]OP-801 for Use as Imaging Agent– The study will evaluate the safety, tolerability and ability of [18F]OP-801 to cross the blood brain barrier and selectively target neuroinflammation in individuals with ALS and healthy volunteers – REDWOOD CITY, Calif., Feb. 06, 2023 (GLOBE NEWSWIRE) -- Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company developing novel nanomedicines called hydroxyl dendrimer therapeutics (HDT), today announced that the first patient has been enrolled in a Phase 1/2 clinical study to evaluate the safety, pharmacokinetics and biodistribution of an intravenously administered dose of [18F]OP-801 in healthy volunteers and in patients with amyotrophic lateral sclerosis (ALS) (NCT05395624). [18F]OP-801 is a hydroxyl dendrimer (HD) imaging agent that selectively targets reactive macrophages and microglia – key markers of neuroinflammation. “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 HD technology for treatment of neurological diseases,” said Jeffrey Cleland, Ph.D., chairman, CEO and president of Ashvattha Therapeutics. “With [18F]OP-801, we will be able to estimate HDT uptake in the diseased part of the brain prior to treating patients with the HDT. This approach, if successful, will reduce clinical risk by ensuring the correct amount of drug reaches the target to treat the neurological disease.” Farshad Moaradi, M.D., Ph.D. clinical associate professor of radiology- rad/nuclear medicine at Stanford Medicineadded, “An obstacle to the treatment of neurodegenerative diseases like ALS is ensuring that treatment reaches areas of disease in the brain. 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.” The study is an interventional, non-randomized open-label Phase 1/2 clinical trial to evaluate the safety, pharmacokinetics and biodistribution of a single dose of [18F]OP-801 after intravenous administration to healthy volunteers and patients with ALS. The study will also measure the biodistribution and clearance of the HD imaging agent in both populations and evaluate the uptake of [18F]OP-801 in regions of neuroinflammation in ALS patients using PET/computed tomography (CT) scans. The study is expected to enroll up to 26 participants. About [18F]OP-801 About Ashvattha Therapeutics [1] Henningfield, C.M., Cleland, J.L., Sharma, R., Green, K.N.Selective targeting of plaque-associated microglia through systemic dendrimer administration in an Alzheimer’s disease model. Alzheimer's & Dementia. 2020; Volume 16. Issue S2. https://doi.org/10.1002/alz.040661 Media Contact |