Ashvattha Therapeutics Announces Collaboration with Stanford University for Preclinical Development of a Novel Neuroimaging Agent, OP-801

Potential Imaging of Neuroinflammation in Alzheimer’s and Other Neurodegenerative Diseases

REDWOOD CITY, Calif., December 14, 2020 — Ashvattha Therapeutics, a biotech company focused on developing novel hydroxyl dendrimer therapeutics (HDTs) to treat unmet medical needs in inflammatory, oncology and ocular diseases, today 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.

About Neuroinflammation and OP-801

Reactive macrophages and microglia (cells of the innate immune system) cause sustained increases in pro-inflammatory cytokines and chemokines in a number of diseases. In neurodegenerative diseases, including Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, Huntington’s disease and depression, this pro-inflammatory response creates an environment of neuroinflammation which leads to progressive loss of neuronal function and eventually death. The ability to measure and treat neuroinflammation is critical to the development of successful therapeutics to treat these diseases.

Ashvattha has established, in multiple models of neurodegeneration including animal models of Alzheimer’s disease, that its proprietary hydroxyl dendrimers (HD) cross the blood brain barrier and are selectively taken up by reactive microglia at the site of inflammation and pathology. HDs may offer novel solutions to target reactive microglia in patients with Alzheimer’s disease and other neurodegenerative conditions. To explore this further, Ashvattha is developing OP-801, a radiolabeled (18F) HD which is selectively taken up by reactive macrophages, as a companion diagnostic. OP-801 will be used to assess the degree of neuroinflammation in patients with Alzheimer’s disease and other neurodegenerative diseases.

About Ashvattha Therapeutics

Ashvattha Therapeutics, a clinical-stage biopharmaceutical company, is developing novel therapeutics that target and alter specific cells in areas of diseased tissues. The Company’s targeted platform technology, hydroxyl dendrimers (HD), is exclusively licensed from Johns Hopkins University. HDs chemically conjugated to disease modifying drugs create novel proprietary HD therapeutics (HDTs). Ashvattha has initiated multiple programs with HDTs focused on oncology, age-related macular degeneration (AMD), hyperinflammation in diseases such as COVID-19 and neuroinflammatory diseases such as ALS and Alzheimer’s disease.

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