Ashvattha Neuroinflammation Imaging and Treatment Highlighted at SNMMI 2024 Annual Meeting

13 June 2024

REDWOOD CITY, Calif., June 10, 2024 – Ashvattha Therapeutics, a clinical-stage company focusing on innovative nanomedicine therapeutics, has highlighted new preclinical data showcasing the therapeutic potential of its novel CSF1R tyrosine kinase inhibitor, CSF1R dendranib, in treating multiple sclerosis (MS). This promising development was demonstrated through significant symptom reduction in a mouse model of experimental autoimmune encephalitis (EAE).

The efficacy of this therapeutic approach was further validated by Ashvattha’s proprietary ¹⁸F-OP-801 PET imaging agent, which showed a marked reduction in neuroinflammation following CSF1R dendranib treatment. The findings were presented by a Stanford University collaborator at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2024 Annual Meeting in Toronto. This presentation was distinguished by a nomination for the Brain Imaging Council Young Investigator Award.

Key highlights from the presentation include:

1. Early Detection and Monitoring: PET imaging with ¹⁸F-OP-801 successfully detected activated immune cells in the EAE model of MS prior to symptom onset.
2. Therapeutic Efficacy: Treatment with CSF1R dendranib significantly mitigated the progression of EAE, showing effectiveness comparable to the FDA-approved MS drug, fingolimod.
3. Correlation with Symptom Reduction: A decrease in the ¹⁸F-OP-801 PET signal was observed, consistent with symptom reduction in both treatment groups compared to the disease control group. This indicates the potential of ¹⁸F-OP-801 as a tool for monitoring therapeutic responses.
4. Immune Cell Reduction: Flow cytometry analysis confirmed that CSF1R dendranib effectively reduced microglial and infiltrating myeloid and T cell populations in the spinal cords of EAE mice.

Dr. Michelle L. James, an Assistant Professor at Stanford University School of Medicine, Department of Radiology and Department of Neurology and Neurological Sciences, emphasized the significance of these results. "There remains an important unmet medical need for imaging agents that enable monitoring of pathophysiologic and therapeutic responses in neuroinflammatory conditions, including MS. Our study demonstrated that ¹⁸F-OP-801 enables early detection of neuroinflammation in a well-established preclinical model of MS. Excitingly, the imaging signal and symptoms decreased with CSF1R dendranib treatment, thus warranting further investigation of both the therapy and imaging agent," she said.

Jeff Cleland, Ph.D., CEO of Ashvattha Therapeutics, reinforced the importance of these findings. "These results provide preclinical validation for our strategy to develop ¹⁸F-OP-801 as a companion biomarker to treatment with CSF1R dendranib in an image-treat-reimage paradigm for patients with MS and other neuroinflammatory conditions. In parallel, our Phase 2 study evaluating the ability of ¹⁸F-OP-801 to cross the human blood-brain barrier and selectively target neuroinflammation in patients with multiple sclerosis, amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and Parkinson’s disease is anticipated to have initial results this summer," he noted.

Ashvattha Therapeutics is at the forefront of creating a new class of nanomedicine therapeutics designed to cross tissue barriers and selectively target activated cells in inflamed regions. This approach aims to set a new standard in precision medicine across various fields, including ophthalmology, neurology, and inflammation. 

These advancements highlight Ashvattha’s commitment to developing transformative treatments for neuroinflammatory diseases, with the potential to significantly impact patient care and outcomes. The ongoing research and future clinical trials are keenly anticipated by the scientific community as they hold promise for advancing therapeutic and diagnostic methodologies in the realm of neuroinflammatory conditions.

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