Vigil Neuroscience Inc ( VIGL ). released interim data on Wednesday from its ongoing Phase 1 clinical trial of VG-3927 in healthy volunteers.

VG-3927 is a novel small molecule TREM2 agonist to treat common neurodegenerative diseases associated with microglial dysfunction, with an initial focus on Alzheimer's disease (AD) patients, including some who carry TREM2 and other disease-associated variants.

The interim safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile support the continued clinical development of VG-3927 as a potential once-daily oral therapy for Alzheimer's disease.

Additionally, these data showed that VG-3927 demonstrated functional and durable target engagement.

The ongoing trial is a Phase 1 single and multiple ascending dose trial to assess the safety, tolerability, PK, and PD of VG-3927.

As of June 30, 2024, the trial had enrolled 80 healthy volunteers, of which 60 have received VG-3927 across multiple single and multiple ascending dose cohorts.

Key takeaways from the interim data include the following:

The safety and tolerability profile observed in individual doses in six single and multiple ascending dose cohorts in the ongoing Phase 1 clinical trial supports the continued clinical development of VG-3927.

All adverse events (AEs) were mild or moderate in severity and resolved without intervention. No serious adverse events have been reported to date.

VG-3927 demonstrated a predictable PK profile that is supportive of once-daily dosing.

VG-3927 achieved a robust and sustained decrease of sTREM2 in the CSF in single and multiple ascending dose cohorts.

After repeat dosing, VG-3927 also showed an increase in osteopontin/secreted phosphoprotein 1 (SPP1), a biomarker associated with neuroprotective microglia.

To date, no effect on soluble Colony Stimulating Factor 1 Receptor (sCSF1R), a microglial trophic factor, has been observed.

As part of the Phase 1 clinical trial, the company has commenced screening for a cohort of Alzheimer's disease patients, including some participants who carry TREM2 or other disease-related variants, to explore the biomarker response of VG-3927 after a single dose.

Vigil plans to report the complete Phase 1 clinical data, including data from the AD patient cohort, in the first quarter of 2025.

Price Action: VIGL stock is up 6.52% at $4.25 at the last check on Wednesday.

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