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- Findings from ILLUMINATE Natural History Study show that MRI and fluid biomarkers are emerging as key measures of ALSP pathophysiology -
- Positive interim IGNITE Phase 2 data demonstrating iluzanebart (VGL101) as potential disease-modifying therapy for ALSP
WATERTOWN, Mass., April 17, 2024 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (NASDAQ:VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced the presentation of multiple oral and poster presentations on the Company's lead clinical candidate iluzanebart at the 2024 American Academy of Neurology (AAN) Annual Meeting.
"We are excited to see our enthusiasm for iluzanebart matched by clinical leaders in the ALSP community. The interim findings from both the IGNITE Phase 2 and ILLUMINATE Natural History studies support the potential of iluzanebart to become the first, disease-modifying therapy for those living with ALSP," said Petra Kaufmann, M.D., F.A.A.N, Chief Medical Officer of Vigil. "Both trials have led to an incredible step forward – not only in understanding ALSP disease progression, but also in drawing parallels between biomarkers and correlating clinical outcomes. We look forward to advancing the clinical development of iluzanebart in the hopes of providing a potentially transformative treatment option for those who have been impacted by this devastating disease."
Oral presentation presented by Zbigniew Wszolek, M.D., Mayo Clinic, Jacksonville: Interim Results on iluzanebart (VGL101) From IGNITE: First Interventional Phase 2 Study in Patients with Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP)
"Vigil's interim IGNITE data demonstrated that iluzanebart was well-tolerated, and the data suggest a favorable impact on the protein product of the CSF1R gene whose dysfunction is the causal driver of ALSP," said Zbigniew Wszolek, M.D., consultant in the Department of Neurology at the Mayo Clinic. "Positive trends on MRI measurements support slowing in irreversible neurodegeneration, and to see these signals in patients as early as six months is very encouraging."
Interim analysis of the Phase 2 IGNITE proof-of-concept, multicenter, open-label study evaluating safety, tolerability, and clinical effects of iluzanebart demonstrated:
Poster presented by David S. Lynch, M.D., Ph.D., National Hospital for Neurology & Neurosurgery; University College London Institute of Neurology: Findings from the ILLUMINATE Prospective Natural History Study (NHS) in Individuals with Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP)
"The findings from ILLUMINATE highlight sensitive markers of ALSP pathophysiology that have the potential to provide valuable insight into clinical endpoints and improve the overall understanding of ALSP disease progression to inform future study designs," said David Lynch, Ph.D., Honorary Research Fellow, Department of Neuromuscular Diseases, University College London.
Data on clinical measures, biomarkers, and MRI from ILLUMINATE were presented at the conference. Key findings included:
Poster presented by Abbie Renoux, Ph.D., Vigil Neuroscience: VGL101: An Immunotherapy that Enhances Microglial Survival for Adult Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP)
The preclinical study demonstrated iluzanebart as a highly potent human TREM2 (hTREM2) agonist monoclonal antibody, and preclinically validated its pharmacological potential to therapeutically circumvent CSF1R dysfunction in human microglia, the pathophysiological process underlying ALSP. Key supportive findings highlighting the mechanism of action of iluzanebart included:
The presentation and posters are accessible on the Publications page of the Company's website.
Posted In: VIGL