Vigil Neuroscience Announces Multiple Presentations on Lead Indication ALSP at the 2023 American Academy of Neurology Annual Meeting

Rhea-AI Summary

Vigil Neuroscience, Inc. (Nasdaq: VIGL) announced its participation in the 2023 American Academy of Neurology Annual Meeting, showcasing multiple oral and poster presentations on adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The disease is rare and lacks approved therapies. Presentations will discuss VGL101, Vigil's lead product candidate, currently in a Phase 2 trial, and findings from interim data related to ALSP's clinical characteristics and misdiagnosis issues. ALSP affects approximately 10,000 individuals in the US, highlighting an urgent need for effective treatments.

Positive

• Vigil's VGL101 is in a Phase 2 clinical trial for ALSP, indicating ongoing development progress.
• The presentations at AAN will share key findings, enhancing awareness and understanding of ALSP.

Negative

• ALSP has no approved therapies, highlighting the challenges Vigil may face in bringing VGL101 to market.

WATERTOWN, Mass., March 02, 2023 (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 multiple oral and poster presentations on adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) at the 2023 American Academy of Neurology (AAN) Annual Meeting taking place on April 22-27, 2023, in Boston, MA and virtually.

“ASLP is a rare, rapidly progressing and underdiagnosed neurodegenerative disease with no approved therapies,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. “As we advance clinical development of VGL101 in our IGNITE Phase 2 trial in ALSP patients, we remain focused on continuing to evolve our understandings of this fatal genetic condition to enable the development of a safe and effective therapy. We look forward to presenting at AAN key findings and considerations for ALSP including its diverse phenotype, radiological features, reasons for misdiagnosis and disease progression. Presentations will also include highlights from the VGL101 Phase 1 interim topline data we reported in November and the ILLUMINATE natural history study interim data shared at our ALSP KOL Event in December.”

Details of the three oral presentations are as follows:

Title: “A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Intravenous Dose Study of a novel TREM2 agonist (VGL101) in Healthy Volunteers (HVs)”
Session: S14: General Neurology: Emerging Therapies
Date and time: Monday, April 24 at 1:36 PM ET

Title: “A Prospective Natural History Study of Patients with Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP)”
Session: S49: General Neurology
Date and time: Thursday, April 27 at 4:54 PM ET

Title: “Refining the phenotype of adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a commonly misdiagnosed autosomal dominant neurodegenerative disease”
Session: S49: General Neurology
Date and time: Thursday, April 27 at 5:18 PM ET

Details of the two poster presentations are as follows:

Title: “Radiological features of adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) and its longitudinal progression”
Session: P8: General Neurology: Neuroimaging 
Date and time: Tuesday, April 25 from 11:45 AM to 12:45 PM ET

Title: “Adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) is commonly misdiagnosed as Frontotemporal Dementia (FTD), Multiple Sclerosis (MS), Alzheimer’s disease (AD), or other adult-onset leukodystrophies”
Session: P12: General Neurology: Neurogenetics 2 
Date and time: Wednesday, April 26 from 5:30 PM to 6:30 PM ET

The posters can be accessed on the Publications page of the Company’s website after the sessions listed above.

About VGL101
VGL101, Vigil’s lead product candidate, is a fully human monoclonal antibody targeting human triggering receptor expressed on myeloid cells 2 (TREM2), which is responsible for maintaining microglial cell function. TREM2 deficiency is believed to be a driver of certain neurodegenerative diseases. VGL101 is in development for rare microgliopathies, such as ALSP, as well as other neurodegenerative diseases for which TREM2 and/or microglia deficiency is believed to be a key driver of disease pathway.

About ALSP
ALSP is a rare, inherited, autosomal dominant neurological disease with high penetrance. It is caused by a mutation to the CSF1R gene and affects an estimated 10,000 people in the US, with similar prevalence in Europe and Japan. The disease generally presents itself in adults in their forties, is diagnosed through genetic testing and established clinical/radiologic criteria and is characterized by cognitive dysfunction, neuropsychiatric symptoms, and motor impairment. These symptoms typically exhibit rapid progression with a life expectancy of approximately six to seven years on average after diagnosis, causing significant patient and caregiver burden. There are currently no approved therapies for the treatment of ALSP, underlining the high unmet need in this rare indication.

About Vigil Neuroscience
Vigil Neuroscience is a clinical-stage biotechnology company focused on developing treatments for both rare and common neurodegenerative diseases by restoring the vigilance of microglia, the sentinel immune cells of the brain. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities in our efforts to develop precision-based therapies to improve the lives of patients and their families. VGL101, our lead candidate, is a fully human monoclonal antibody agonist targeting human triggering receptor expressed on myeloid cells 2 (TREM2) and is in a Phase 2 proof-of-concept trial in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a rare and fatal neurodegenerative disease. We are also conducting IND-enabling studies with a novel small molecule TREM2 agonist program to treat common neurodegenerative diseases associated with microglial dysfunction, with an initial focus on Alzheimer’s disease (AD) in genetically defined subpopulations.

FAQ

What is the significance of VIGL's presentations at the 2023 AAN Annual Meeting?

VIGL's presentations will provide essential data on ALSP and VGL101, increasing awareness and understanding of the disease.

What is the current status of VGL101?

VGL101 is currently in a Phase 2 clinical trial targeting ALSP, showing Vigil's commitment to developing therapies for rare neurodegenerative diseases.

How many people are affected by ALSP in the US?

Approximately 10,000 people in the US are estimated to be affected by adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP).

What are the key presentations focusing on VGL101 at the AAN meeting?

Key presentations will cover VGL101's Phase 1 data, the natural history of ALSP, and its misdiagnosis related to other neurodegenerative diseases.

What challenges does Vigil face in developing treatments for ALSP?

The primary challenge is that ALSP currently has no approved therapies, underscoring the clinical need and hurdles in bringing VGL101 to market.