Ashvattha Therapeutics, a biotech company focused on developing novel hydroxyl dendrimer therapeutics (HDTs) to treat unmet medical needs in inflammatory, oncology and ocular diseases, announced the initiation of a preclinical proof of concept study for OP-801 imaging of neuroinflammation. This Investigational New Drug (IND)-enabling research will be conducted in collaboration with a team of researchers at the Stanford University School of Medicine led by Michelle James, Ph.D., Assistant Professor of Radiology and Neurology.
Ashvattha is developing OP-801 as a neuroimaging agent to diagnose patients with neuroinflammation due to Alzheimer’s disease, amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. OP-801 is being developed as a companion diagnostic and also a pharmacodynamic tool for therapeutics to treat neuroinflammation.
“Currently available imaging agents for detecting neuroinflammation in Alzheimer’s and other neurodegenerative diseases have many limitations; the main limitation is a lack of specificity to reactive inflammatory cells, in particular, reactive microglia, which OP-801 is designed to target,” said Jeffrey Cleland, Ph.D., chairman, CEO and president of Ashvattha Therapeutics. “Preclinical studies across six animal species have demonstrated HDs cross the blood brain barrier and are selectively taken up only in reactive microglia. We look forward to rapidly progressing the preclinical imaging research for OP-801, as this research may lead to the development of a powerful tool for diagnosis and treatment of neurodegenerative diseases such as Alzheimer’s.”
Following the conclusion of the OP-801 preclinical imaging research, Ashvattha plans to initiate a Phase 1 study of OP-801 in the second half of 2021.